Budesonide (Budesonide)

Trade Name : Budesonide

Teva Pharmaceuticals USA, Inc.

SUSPENSION

Strength 1 mg/2mL

BUDESONIDE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Budesonide (Budesonide) which is also known as Budesonide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1 mg/2mL per ml. Read more

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Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use:
Budesonide inhalation suspension is an inhaled corticosteroid indicated for:
Limitations of Use
Not indicated for the relief of acute bronchospasm ()

Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ()

The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table.
Recommended dosing based on previous therapy (). Start with the lowest recommended dose:

Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily
Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily
Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily
In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered
If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. Once asthma stability is achieved, titrate the dose downwards.
For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. ()

Budesonide inhalation suspension is available in one strength, containing 2 mL: 1 mg/2 mL. Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose ampules. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile liquid suspension.
Inhalation suspension: 1 mg/2 mL ()

The use of budesonide inhalation suspension is contraindicated in the following conditions:

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required ()
Hypersensitivity to any of the ingredients in budesonide inhalation suspension ()

No data

Localized Infections:n- Candida albicans
Deterioration of Disease and Acute Asthma Episodes:
Hypersensitivity Reactions:
Immunosuppression:
Transferring Patients from Systemic Corticosteroid Therapy:
Hypercorticism and Adrenal Suppression:
Reduction in Bone Mineral Density with Long-term Administration:
Effects on Growth:
Glaucoma and Cataracts:
Paradoxical Bronchospasm:
Eosinophilic Conditions and Churg-Strauss Syndrome:

Systemic and inhaled corticosteroid use may result in the following:
Most common adverse reactions (incidence 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ()
To report SUSPECTED ADVERSE REACTIONS, contact u00a0at 1-800-FDA-1088 or www.fda.gov/medwatch

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of budesonide inhalation suspension with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [].
Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects (, )

No data

The potential for acute toxic effects following overdose of budesonide inhalation suspension is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur [].

Budesonide, USP, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as ()-11u03b2,16u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide, USP is provided as a mixture of two epimers (22R and 22S). Its structural formula is:
u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 CHOu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0M.W. 430.5
Budesonide, USP is a white or almost white, crystalline powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10.
Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide, USP (micronized), and the inactive ingredients citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, tri-sodium citrate dihydrate and water for injection. It is available in single-dose ampules: 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [].

No data

In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis). No tumorigenicity was seen in male rats at oral doses up to 25 mcg/kg (approximately 0.2 and 0.04 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis) and in female rats at oral doses up to 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis). In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis). However, in the male Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) in these two studies showed similar findings.
In a 91 week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately equivalent to and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/mbasis).
Budesonide was not mutagenic or clastogenic in six different test systems: Ames /microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in , and DNA repair analysis in rat hepatocyte culture.
Fertility and reproductive performance were unaffected in rats at subcutaneous doses up to 80 mcg/kg approximately equivalent to the MRHDID in adults on a mcg/mbasis. However, it caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg and above approximately 0.2 times than the MRHDID in adults on a mcg/m basis. No such effects were noted at 5 mcg/kg (approximately 0.05 times the MRHDID in adults on a mcg/m basis).

Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12 weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, 657 males and 361 females (798 Caucasians, 140 Blacks, 56 Hispanics, 3 Asians, 21 Others) with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25 mg, 0.5 mg, and 1 mg administered either once or twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to patients in the 3 U.S. controlled clinical trials. The co-primary endpoints were nighttime and daytime asthma symptom scores (0 to 3 scale). Improvements were addressed in terms of the primary efficacy variables of changes from baseline to the double-blind treatment period in nighttime and daytime asthma symptom scores (scale 0 to 3) as recorded in the patient diaries. Baseline was defined as the mean of the last seven days prior to randomization. The double-blind treatment period was defined as the mean over 12 week treatment period. Each of the five doses discussed below were studied in one or two, but not all three of the U.S. studies.
Results of the 3 controlled clinical trials for recommended dosages of budesonide inhalation suspension (0.25 mg to 0.5 mg once or twice daily, or 1 mg once daily, up to a total daily dose of 1 mg) in 946 patients, 12 months to 8 years of age, are presented below. Statistically significant decreases in nighttime and daytime symptom scores of asthma were observed at budesonide inhalation suspension doses of 0.25 mg once daily (one study), 0.25 mg twice daily, and 0.5 mg twice daily compared to placebo. Use of budesonide inhalation suspension resulted in statistically significant decreases in either nighttime or daytime symptom scores, but not both, at doses of 1 mg once daily, and 0.5 mg once daily (one study). Symptom reduction in response to budesonide inhalation suspension occurred across gender and age. Statistically significant reductions in the need for bronchodilator therapy were also observed at all the doses of budesonide inhalation suspension studied.
Improvements in lung function were associated with budesonide inhalation suspension in the subgroup of patients capable of performing lung function testing. Statistically significant increases were seen in FEV [budesonide inhalation suspension 0.5 mg once daily and 1 mg once daily (one study); 0.5 mg twice daily] and morning PEF [budesonide inhalation suspensionu00a01 mg once daily (one study); 0.25 mg twice daily; 0.5 mg twice daily] compared to placebo.
A numerical reduction in nighttime and daytime symptom scores (0 to 3 scale) of asthma was observed within 2 to 8 days, although maximum benefit was not achieved for 4 to 6 weeks after starting treatment. The reduction in nighttime and daytime asthma symptom scores was maintained throughout the 12 weeks of the double-blind trials.
Patients Not Receiving Inhaled Corticosteroid Therapy
The efficacy of budesonide inhalation suspension at doses of 0.25 mg, 0.5 mg, and 1 mg once daily was evaluated in 344 pediatric patients, 12 months to 8 years of age, with mild to moderate persistent asthma (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.07 to 1.34) who were not well controlled by bronchodilators alone. The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in . Nighttime asthma symptom scores showed statistically significant decreases in the patients treated with budesonide inhalation suspension compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
Changes from baseline to the double-blind phase for the budesonide treatment groups compared to placebo were made using analysis of variance techniques. The model included terms for the respective changes from baseline as the dependent variable and terms for treatment, center and treatment by center interaction as exploratory variables (see to ).
Patients Previously Maintained on Inhaled Corticosteroids
The efficacy of budesonide inhalation suspension at doses of 0.25 mg and 0.5 mg twice daily was evaluated in 133 pediatric asthma patients, 4 to 8 years of age, previously maintained on inhaled corticosteroids (mean FEV 79.5% predicted; mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.04 to 1.18; mean baseline dose of beclomethasone dipropionate of 265 mcg/day, ranging between 42 to 1008 mcg/day; mean baseline dose of triamcinolone acetonide of 572 mcg/day, ranging between 200 to 1200 mcg/day). The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in . Nighttime asthma symptom scores showed statistically significant decrease in patients treated with budesonide inhalation suspension compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
Statistically significant increases in FEV compared to placebo were observed with budesonide inhalation suspension at a dose of 0.5 mg twice daily and in morning PEF for both doses (0.25 mg and 0.5 mg twice daily).
Patients Receiving Once-Daily or Twice-Daily Dosing
The efficacy of budesonide inhalation suspension at doses of 0.25 mg once daily, 0.25 mg twice daily, 0.5 mg twice daily, and 1 mg once daily, was evaluated in 469 pediatric patients 12 months to 8 years of age (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.13 to 1.31). Approximately 70% were not previously receiving inhaled corticosteroids. The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in . Budesonide inhalation suspension at doses of 0.25 mg and 0.5 mg twice daily, and 1 mg once daily, demonstrated statistically significant decreases in nighttime asthma symptom scores compared to placebo. Similar decreases were also observed for daytime asthma symptom scores.
Budesonide inhalation suspension at a dose of 0.5 mg twice daily resulted in statistically significant increases compared to placebo in FEV, and at doses of 0.25 mg and 0.5 mg twice daily and 1 mg once daily statistically significant increases in morning PEF.
The evidence supports the efficacy of the same nominal dose of budesonide inhalation suspension administered on either a once-daily or twice-daily schedule. However, when all measures are considered together, the evidence is stronger for twice-daily dosing [].

Illustrated accompany each package of budesonide inhalation suspension.
Budesonide inhalation suspension, 1 mg/2 mL is supplied in a sealed aluminum foil envelope containing one plastic strip of five single-dose ampules. Each single-dose ampule contains 2 mL of sterile liquid suspension, supplied in unit-dose cartons of 30 ampules (6 pouches x 5 ampules) (NDC 0093-6817-73).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Store upright and protect from light.
When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected. After opening the aluminum foil envelope, the unused ampules should be returned to the aluminum foil envelope to protect them from light. Any opened ampule must be used promptly. Gently shake the ampule using a circular motion before use. Keep out of reach of children. Do not freeze.

No data

Budesonide (bew DEH so nide) Inhalation Suspension
2 mL ampules containing 1 mg
Read the Patient Information that comes with budesonide inhalation suspension before your child starts using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your childu2019s medical condition or treatment. If you have any questions about budesonide inhalation suspension, ask your healthcare provider or pharmacist.
What is budesonide inhalation suspension?
Budesonide inhalation suspension is an inhaled corticosteroid medicine. Budesonide inhalation suspension is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. Budesonide inhalation suspension helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms.
Budesonide inhalation suspension does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. Always have a short-acting beta-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child.
It is not known if budesonide inhalation suspension is safe or effective in children younger than 12 months or older than 8 years.
Who should not use budesonide inhalation suspension?
Do not use budesonide inhalation suspension:
What should I tell my healthcare provider before using budesonide inhalation suspension?
Before your child uses budesonide inhalation suspension, tell your healthcare provider if your child:
Budesonide inhalation suspension may not be right for children who have had any of these types of infections.
Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using budesonide inhalation suspension with certain other medicines may affect each other causing side effects. Especially tell your healthcare provider if your child takes:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine.
How should I use budesonide inhalation suspension?
What are the possible side effects of budesonide inhalation suspension?
Budesonide inhalation suspension may cause serious side effects including:
Call your healthcare provider or get medical help right away if your child has any of the serious side effects listed above.
The most common side effects of budesonide inhalation suspension include:
Tell your healthcare provider if your child has any side effect that bothers him or her or that does not go away.
For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or the FDAu00a0at 1-800-FDA-1088 or www.fda.gov/medwatch.
How should I store budesonide inhalation suspension?
Keep budesonide inhalation suspension and all medicines out of the reach of children.
General Information about budesonide inhalation suspension
Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use budesonide inhalation suspension for a condition for which it was not prescribed. Do not give budesonide inhalation suspension to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about budesonide inhalation suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about budesonide inhalation suspension that is written for health professionals.
For more information, call 1-888-838-2872.
What are the ingredients in budesonide inhalation suspension?
Active ingredient: budesonide
Inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, tri-sodium citrate dihydrate and water for injection.
Patient Instructions for Use
Important:
Budesonide inhalation suspension is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses budesonide inhalation suspension.
Budesonide inhalation suspension is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs.
The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.
1. Budesonide inhalation suspension ampules come in a sealed protective aluminum foil envelope.
Return the unopened budesonide inhalation suspension ampules on the strip back into the foil envelope before storing.
2. Gently shake the budesonide inhalation suspension ampule using a circular motion as shown in .
3. Hold the budesonide inhalation suspension ampule upright without squeezing the ampule and open by twisting off the top as shown in .
4. Place the open end of the budesonide inhalation suspension ampule into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the ampule into the nebulizer medicine cup as shown in . Throw away the empty ampule.
5. Use your jet nebulizer as directed.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In England By:
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
Runcorn, Cheshire WA7 3FA England
Manufactured For:
Arrayn- Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. A 10/2019

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Budesonide (Budesonide)

Trade Name : Budesonide

SUSPENSION

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

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Budesonide (Budesonide)

Trade Name : Budesonide

SUSPENSION

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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