Sildenafil (Sildenafil)

Trade Name : Sildenafil

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 25 mg/1

SILDENAFIL CITRATE Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sildenafil (Sildenafil) which is also known as Sildenafil and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25 mg/1 per ml. Read more

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Warnings and Precautions, Effects on the Eye () 08/2017

Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ()

No data

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ()
Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ()
Maximum recommended dosing frequency is once per day ()

Sildenafil tablets USP are supplied as white to off-white, film-coated, modified oval-shaped, convex tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with u201cTEVAu201d on one side and u201c5341u201d for 25 mg, u201c5342u201d for 50 mg, and u201c5343u201d for 100 mg on the other side.
Tablets: 25 mg, 50 mg, 100 mg ()

No data

Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates (, , )
Known hypersensitivity to sildenafil or any component of tablet ()
Administration with guanylate cyclase (GC) stimulators, such as riociguat ()

No data

Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ()
Patients should seek emergency treatment if an erection lasts > 4 hours. Use sildenafil with caution in patients predisposed to priapism ()
Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a u201ccrowdedu201d optic disc may also be at an increased risk of NAION. ()
Patients should stop sildenafil and seek prompt medical attention in the event of sudden decrease or loss of hearing ()
Caution is advised when sildenafil is coadministered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension ()
Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil dosage is recommended (, )

The following are discussed in more detail in other sections of the labeling:
The most common adverse reactions reported in clinical trials (> 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
Most common adverse reactions (u2265 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ()
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (, , , , , )
With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ()
CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure (, , ) n

No data

Geriatric use: Consider a starting dose of 25 mg (, )
Severe renal impairment: Consider a starting dose of 25 mg (, )
Hepatic impairment: Consider a starting dose of 25 mg (, )

In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1-pyrazolo[4,3-]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
CHNOSu2022CHO M.W. 666.7
Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol u2013 part. hydrolyzed, talc, and titanium dioxide.

No data

Carcinogenesis
Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20- and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m basis in a 50 kg subject.
Mutagenesis
Sildenafil was negative in bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and human lymphocytes and mouse micronucleus assays to detect clastogenicity.
Impairment of Fertility
There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC.

In clinical studies, sildenafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Sildenafil was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). Sildenafil was administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. Sildenafil demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.
Arrayn- Efficacy Endpoints in Controlled Clinical Studies
The effectiveness of sildenafil was evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function - IIEF) administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction. Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.
Arrayn- Efficacy Results from Controlled Clinical Studies
The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil was better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients who were less impaired at baseline.
The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7. These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions. Erectile dysfunction was attributed to organic (58%; generally not characterized, but including diabetes and excluding spinal cord injury), psychogenic (17%), or mixed (24%) etiologies. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil, respectively, reported an improvement in their erections, compared to 24% on placebo. In the titration studies (n = 644) (with most patients eventually receiving 100 mg), results were similar.
The patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.
In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil vs about 20% on placebo.
During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil improved their erections.
Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.
One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n = 268). As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil compared to placebo. On a global improvement question, 57% of sildenafil patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil, 48% of intercourse attempts were successful versus 12% on placebo.
One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n = 178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil. On a global improvement question, 83% of patients reported improved erections on sildenafil versus 12% on placebo. Diary data indicated that on sildenafil, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.
Across all trials, sildenafil improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.
Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n = 179) and two titration studies (total n = 149) showed 84% of sildenafil patients reported improvement in erections compared with 26% of placebo. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil. Diary data in two of the studies (n = 178) showed rates of successful intercourse per attempt of 70% for sildenafil and 29% for placebo.
Arrayn- Efficacy Results in Subpopulations in Controlled Clinical Studies
A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics.

Sildenafil tablets USP, 25 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with u201cTEVAu201d on one side and u201c5341u201d on the other side, in bottles of 30 (NDC 0093-5341-56).
Sildenafil tablets USP, 50 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with u201cTEVAu201d on one side and u201c5342u201d on the other side, in bottles of 30 (NDC 0093-5342-56) and 100 (NDC 0093-5342-01).
Sildenafil tablets USP, 100 mg are available as white to off-white, film-coated, modified oval-shaped, convex tablets debossed with u201cTEVAu201d on one side and u201c5343u201d on the other side, in bottles of 30 (NDC 0093-5343-56) and 100 (NDC 0093-5343-01).
Recommended Storage:
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Advise the patient to read the FDA-approved patient labeling (Patient Information)
Nitrates
Physicians should discuss with patients the contraindication of sildenafil with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [].
Guanylate Cyclase (GC) Stimulators
Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [n ].
Concomitant Use with Drugs Which Lower Blood Pressure
Physicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is coadministered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [].
Cardiovascular Considerations
Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [].
Sudden Loss of Vision
Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a u201ccrowdedu201d optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil, for this uncommon condition [].
Sudden Hearing Loss
Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [].
Priapism
Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [].
Avoid Use with other PDE5 Inhibitors
Physicians should inform patients not to take sildenafil with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil with other PDE5 inhibitors, including REVATIO, have not been studied [].
Sexually Transmitted Disease
The use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [].
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. D 12/2017

Sildenafil Tablets USP
(sil-DEN-a-fil)
What is the most important information I should know about sildenafil tablets?
Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if they are taken with certain other medicines.
Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:
Tell all your healthcare providers that you take sildenafil tablets.
Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.
Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.
Sildenafil tablets do not protect you or your partner from getting sexually transmitted diseases, including HIVu2014the virus that causes AIDS.
What are sildenafil tablets?
Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets help a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).
Sildenafil tablets are not for use in women or children.
It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.
Who should not take sildenafil tablets?
Do not take sildenafil tablets if you:
What should I tell my healthcare provider before taking sildenafil tablets?
Before you take sildenafil tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take*
Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets work causing side effects. Especially tell your healthcare provider if you take any of the following:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take sildenafil tablets?
What are the possible side effects of sildenafil tablets?
Sildenafil tablets can cause serious side effects.
The most common side effects of sildenafil tablets are:
In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before taking sildenafil tablets. It is not known if sildenafil tablets caused these problems.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store sildenafil tablets?
Keep sildenafil tablets and all medicines out of the reach of children.
General information about the safe and effective use of sildenafil tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sildenafil tablets for a condition for which they were not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. They may harm them.
This Patient Information leaflet summarizes the most important information about sildenafil tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.
For more information, call 1-888-838-2872.
What are the ingredients in sildenafil tablets USP?
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
This productu2019s label may have been updated. For more information, call 1-888-838-2872.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. C 8/2017

No data

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Sildenafil (Sildenafil)

Trade Name : Sildenafil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Sildenafil (Sildenafil)

Trade Name : Sildenafil

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

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