Zafirlukast (Zafirlukast)

Trade Name : Zafirlukast

Major Pharmaceuticals

TABLET, COATED

Strength 20 mg/1

ZAFIRLUKAST Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zafirlukast (Zafirlukast) which is also known as Zafirlukast and Manufactured by Major Pharmaceuticals. It is available in strength of 20 mg/1 per ml. Read more

Zafirlukast (Zafirlukast) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:
The empirical formula is: CHNOS
Zafirlukast, a fine white to pale yellow amorphous powder, is practically insoluble in water. It is slightly soluble in methanol and freely soluble in tetrahydrofuran, dimethylsulfoxide, and acetone.
Zafirlukast is supplied as 10 and 20 mg tablets for oral administration.
Inactive Ingredients:

Mechanism of Action:
Zafirlukast is a selective and competitive receptor antagonist of leukotriene D4 and E4 (LTD4 and LTE4), components of slow-reacting substance of anaphylaxis (SRSA). Cysteinyl leukotriene production and receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle constriction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma. Patients with asthma were found in one study to be 25-100 times more sensitive to the bronchoconstricting activity of inhaled LTD4 than nonasthmatic subjects.
In vitro
inhibited inhaled LTD-induced influx of eosinophils into animal lungs. Inhalational challenge studies in sensitized sheep showed that zafirlukast suppressed the airway responses to antigen; this included both the early- and late-phase response and the nonspecific hyperresponsiveness.
In humans, zafirlukast inhibited bronchoconstriction caused by several kinds of inhalational challenges. Pretreatment with single oral doses of zafirlukast inhibited the bronchoconstriction caused by sulfur dioxide and cold air in patients with asthma. Pretreatment with single doses of zafirlukast attenuated the early- and late-phase reaction caused by inhalation of various antigens such as grass, cat dander, ragweed, and mixed antigens in patients with asthma. Zafirlukast also attenuated the increase in bronchial hyperresponsiveness to inhaled histamine that followed inhaled allergen challenge.
Clinical Pharmacokinetics and Bioavailability:
Absorption
Zafirlukast is rapidly absorbed following oral administration. Peak plasma concentrations are generally achieved 3 hours after oral administration. The absolute bioavailability of zafirlukast is unknown. In two separate studies, one using a high fat and the other a high protein meal, administration of zafirlukast with food reduced the mean bioavailability by approximately 40%.
Distribution
Zafirlukast is more than 99% bound to plasma proteins, predominantly albumin. The degree of binding was independent of concentration in the clinically relevant range. The apparent steady-state volume of distribution (Vss/F) is approximately 70 L, suggesting moderate distribution into tissues. Studies in rats using radiolabeled zafirlukast indicate minimal distribution across the blood-brain barrier.
Metabolism
Zafirlukast is extensively metabolized. The most common metabolic products are hydroxylated metabolites which are excreted in the feces. The metabolites of zafirlukast identified in plasma are at least 90 times less potent as LTD receptor antagonists than zafirlukast in a standard test of activity. studies using human liver microsomes showed that the hydroxylated metabolites of zafirlukast excreted in the feces are formed through the cytochrome P450 2C9 (CYP2C9) pathway. Additional studies utilizing human liver microsomes show that zafirlukast inhibits the cytochrome P450 CYP3A4 and CYP2C9 isoenzymes at concentrations close to the clinically achieved total plasma concentrations (see Drug Interactions).
Excretion
The apparent oral clearance (CL/f) of zafirlukast is approximately 20 L/h. Studies in the rat and dog suggest that biliary excretion is the primary route of excretion. Following oral administration of radiolabeled zafirlukast to volunteers, urinary excretion accounts for approximately 10% of the dose and the remainder is excreted in feces. Zafirlukast is not detected in urine.
In the pivotal bioequivalence study, the mean terminal half-life of zafirlukast is approximately 10 hours in both normal adult subjects and patients with asthma. In other studies, the mean plasma half-life of zafirlukast ranged from approximately 8 to 16 hours in both normal subjects and patients with asthma. The pharmacokinetics of zafirlukast are approximately linear over the range from 5 mg to 80 mg. Steady-
state plasma concentrations of zafirlukast are proportional to the dose and predictable from single-dose pharmacokinetic data. Accumulation of zafirlukast in the plasma following twice-daily dosing is approximately 45%.
The pharmacokinetic parameters of zafirlukast 20 mg administered as a single dose to 36 male volunteers are shown with the table below.
Special Populations
Gender:The pharmacokinetics of zafirlukast are similar in males and females. Weight-adjusted apparent oral clearance does not differ due to gender.
Race: No differences in the pharmacokinetics of zafirlukast due to race have been observed.
Elderly: The apparent oral clearance of zafirlukast decreases with age. In patients above 65 years of age, there is an approximately 2-3 fold greater C and AUC compared to young adult patients.
Children: Following administration of a single 20 mg dose of zafirlukast to 20 boys and girls between 7 and 11 years of age, and in a second study, to 29 boys and girls between 5 and 6 years of age, the following pharmacokinetic parameters were obtained:
Weight unadjusted apparent clearance was 11.4 L/h (42%) in the 7-11 year old children and 9.2 L/h (37%) in the 5-6 year old children, which resulted in greater systemic drug exposures than that obtained in adults for an identical dose. To maintain similar exposure levels in children compared to adults, a dose of 10 mg twice daily is recommended in children 5-11 years of age (see DOSAGE AND ADMINISTRATION).
Zafirlukast disposition was unchanged after multiple dosing (20 mg twice daily) in children and the degree of accumulation in plasma was similar to that observed in adults.
Hepatic Insufficiency: In a study of patients with hepatic impairment (biopsy-proven cirrhosis), there was a reduced clearance of zafirlukast resulting in a 50-60% greater C and AUC compared to normal subjects.
Renal Insufficiency: Based on a cross-study comparison, there are no apparent differences in the pharmacokinetics of zafirlukast between renally-impaired patients and normal subjects.
Drug-Drug Interactions:
Clinical Studies:
Three U.S. double-blind, randomized, placebo-controlled, 13-week clinical trials in 1380 adults and children 12 years of age and older with mild-to-moderate asthma demonstrated that zafirlukast improved daytime asthma symptoms, nighttime awakenings, mornings with asthma symptoms, rescue beta-agonist use, FEV, and morning peak expiratory flow rate. In these studies, the patients had a mean baseline FEV of approximately 75% of predicted normal and a mean baseline beta-agonist requirement of approximately 4-5 puffs of albuterol per day. The results of the largest of the trials are shown in the table below.
Mean Change from Baseline at Study End Point
In a second and smaller study, the effect of zafirlukast on most efficacy parameters was comparable to the active control (inhaled cromolyn sodium 1600 mcg four times per day) and superior to placebo at end point for decreasing rescue beta-agonist use (figure below).
In these trials, improvement in asthma symptoms occurred within one week of initiating treatment with zafirlukast. The role of zafirlukast in the management of patients with more severe asthma, patients
receiving antiasthma therapy other than as-needed, inhaled beta-agonists, or as an oral or inhaled corticosteroid-sparing agent remains to be fully characterized.

Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

Zafirlukast is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients.
Zafirlukast is contraindicated in patients with hepatic impairment including hepatic cirrhosis.

Hepatotoxicity:
Cases of life-threatening hepatic failure have been reported in patients treated with zafirlukast. Cases of liver injury without other attributable cause have been reported from post-marketing adverse event surveillance of patients who have received the recommended dose of zafirlukast (40 mg/day). In most, but not all post-marketing reports, the patientu2019s symptoms abated and the liver enzymes returned to normal or near normal after stopping zafirlukast. In rare cases, patients have either presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death. In extremely rare post-marketing cases, no clinical symptoms or signs suggestive of liver dysfunction were reported to precede the latter observations.
Physicians may consider the value of liver function testing. Periodic serum transaminase testing has not proven to prevent serious injury but it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery.
Patients should be advised to be alert for signs and symptoms of liver dysfunction (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia) and to contact their physician immediately if they occur. Ongoing clinical assessment of patients should govern physician interventions, including diagnostic evaluations and treatment.
If liver dysfunction is suspected based upon clinical signs or symptoms (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, anorexia, and enlarged liver), zafirlukast should be discontinued.
Liver function tests, in particular serum ALT, should be measured immediately and the patient managed accordingly. If liver function tests are consistent with hepatic dysfunction, zafirlukast therapy should not be resumed. Patients in whom zafirlukast was withdrawn because of hepatic dysfunction where no other attributable cause is identified should not be re-exposed to zafirlukast (see PRECAUTIONS, Information for Patients and ADVERSE REACTIONS).
Bronchospasm:
Zafirlukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with zafirlukast can be continued during acute exacerbations of asthma.
Concomitant Warfarin Administration:
Coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time (PT). Patients on oral warfarin anticoagulant therapy and zafirlukast should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see PRECAUTIONS, Drug Interactions).

No data

Adults and Children 12 years of age and older
The safety database for zafirlukast consists of more than 4000 healthy volunteers and patients who received zafirlukast, of which 1723 were asthmatics enrolled in trials of 13 weeks duration or longer. A total of 671 patients received zafirlukast for 1 year or longer. The majority of the patients were 18 years of age or older; however, 222 patients between the age of 12 and 18 years received zafirlukast.
A comparison of adverse events reported by u2265 1% of zafirlukast-treated patients, and at rates numerically greater than in placebo-treated patients, is shown for all trials in the table below.
The frequency of less common adverse events was comparable between zafirlukast and placebo.
Rarely, elevations of one or more liver enzymes have occurred in patients receiving zafirlukast in controlled clinical trials. In clinical trials, most of these have been observed at doses four times higher than the recommended dose. The following hepatic events (which have occurred predominantly in females) have been reported from postmarketing adverse event surveillance of patients who have received the recommended dose of zafirlukast (40 mg/day): cases of symptomatic hepatitis (with or without hyperbilirubinemia) without other attributable cause; and rarely, hyperbilirubinemia without other elevated liver function tests. In most, but not all postmarketing reports, the patientu2019s symptoms abated and the liver enzymes returned to normal or near normal after stopping zafirlukast. In rare cases, patients have presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death (see WARNINGS, Hepatotoxicity and PRECAUTIONS, Information for Patients).
In clinical trials, an increased proportion of zafirlukast patients over the age of 55 years reported infections as compared to placebo-treated patients. A similar finding was not observed in other age groups studied. These infections were mostly mild or moderate in intensity and predominantly affected
the respiratory tract. Infections occurred equally in both sexes, were dose-proportional to total milligrams of zafirlukast exposure, and were associated with coadministration of inhaled corticosteroids. The clinical significance of this finding is unknown.
In rare cases, patients with asthma on zafirlukast may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that zafirlukast may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established (see PRECAUTIONS, Eosinophilic Conditions).
Neuropsychiatric adverse events, including insomnia and depression, have been reported in association with zafirlukast therapy (see PRECAUTIONS, Neuropsychiatric Events). Hypersensitivity reactions, including urticaria, angioedema and rashes, with or without blistering, have also been reported in association with zafirlukast therapy. Additionally, there have been reports of patients experiencing agranulocytosis, bleeding, bruising, or edema, arthralgia, myalgia, malaise, and pruritus in association with zafirlukast therapy.
Rare cases of patients experiencing increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity after the addition of zafirlukast to an existing theophylline regimen have been reported. The mechanism of the interaction between zafirlukast and theophylline in these patients is unknown and not predicted by available metabolism data and the results of two clinical drug interaction studies (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Drug Interactions).
Pediatric Patients 5 through 11 years of age
Zafirlukast has been evaluated for safety in 788 pediatric patients 5 through 11 years of age. Cumulatively, 313 pediatric patients were treated with zafirlukast 10 mg twice daily or higher for at least 6 months, and 113 of them were treated for one year or longer in clinical trials. The safety profile of zafirlukast 10 mg twice daily-versus placebo in the 4- and 6-week double-blind trials was generally similar to that observed in the adult clinical trials with zafirlukast 20 mg twice daily.
In pediatric patients receiving zafirlukast in multi-dose clinical trials, the following events occurred with a frequency of u2265 2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache (4.5 vs. 4.2%) and abdominal pain (2.8 vs. 2.3%).
The post-marketing experience in this age group is similar to that seen in adults, including hepatic dysfunction, which may lead to liver failure.

No deaths occurred at oral zafirlukast doses of 2000 mg/kg in mice (approximately 210 times the maximum recommended daily oral dose in adults and children on a mg/m basis), 2000 mg/kg in rats (approximately 420 times the maximum recommended daily oral dose in adults and children on a mg/m basis), and 500 mg/kg in dogs (approximately 350 times the maximum recommended daily oral dose in adults and children on a mg/m basis).
Overdosage with zafirlukast has been reported in four patients surviving reported doses as high as 200 mg. The predominant symptoms reported following zafirlukast overdose were rash and upset stomach. There were no acute toxic effects in humans that could be consistently ascribed to the administration of zafirlukast. It is reasonable to employ the usual supportive measures in the event of an overdose; eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Because food can reduce the bioavailability of zafirlukast, zafirlukast should be taken at least 1 hour before or 2 hours after meals.
Adults and Children 12 years of age and older
The recommended dose of zafirlukast in adults and children 12 years and older is 20 mg twice daily.
Pediatric Patients 5 through 11 years of age
The recommended dose of zafirlukast in children 5 through 11 years of age is 10 mg twice daily.
Elderly Patients
Based on cross-study comparisons, the clearance of zafirlukast is reduced in elderly patients (65 years of age and older), such that C and AUC are approximately twice those of younger adults. In clinical trials, a dose of 20 mg twice daily was not associated with an increase in the overall incidence of adverse events or withdrawals because of adverse events in elderly patients.
Patients with Hepatic Impairment
Zafirlukast is contraindicated in patients with hepatic impairment including hepatic cirrhosis (see Contraindications). The clearance of zafirlukast is reduced in patients with stable alcoholic cirrhosis such that the C and AUC are approximately 50 - 60% greater than those of normal adults. Zafirlukast has not been evaluated in patients with hepatitis or in long-term studies of patients with cirrhosis.
Patients with Renal Impairment
Dosage adjustment is not required for patients with renal impairment.

Zafirlukast 20 mg Tablets,
Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6646-04
Store at controlled room temperature, 20-25u00b0C (68-77u00b0F) [see USP]. Protect from light and moisture. Dispense in the original air-tight container.

Zafirlukast Tablets
Read the Patient Information leaflet before you start taking zafirlukast and each time you get a refill.u00a0u00a0 There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is Zafirlukast?
Zafirlukast is a prescription medicine used tou00a0 help prevent asthma attacks and for the long-term treatment of asthma symptoms in adults and children 5 years and older.
It is not known if zafirlukast is safe and effective when used in children under 5 years old.u00a0 The effect of zafirlukast on growth in children has not been determined.
Do not take zafirlukast if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
Who should not take Zafirlukast?
Do not take zafirlukast if you:
u00b7u00a0u00a0u00a0
u00b7u00a0u00a0u00a0
What should I tell my healthcare provider before taking Zafirlukast?
Before you take Zafirlukast, tell your healthcare provider if you:
u00b7u00a0u00a0u00a0
u00b7u00a0u00a0u00a0 have any other medical conditions
u00b7u00a0u00a0u00a0
u00b7 u00a0u00a0u00a0u00a0
u00a0
Tell your healthcare provider about all the medicines you take,
Zafirlukast may affect the way other medicines work, and other medicines may affect howu00a0 zafirlukast works.
Especially tell your healthcare provider if you take:
u00b7u00a0u00a0u00a0
u00b7u00a0u00a0u00a0 erythromycin (ERYC, ERY-TAB, PCE)
u00b7u00a0u00a0u00a0 theophylline (Elixophyllin, Theo-24, Theochron, Theolair, Uniphyl)
u00b7u00a0u00a0u00a0 fluconazole (Diflucan)
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Zafirlukast?
What are the possible side effects of Zafirlukast?
u00a0
Zafirlukastmay cause serious side effects, including:
u00a0
u00b7u00a0u00a0u00a0 Store zafirlukast at 68u00b0F to 77u00b0F(20u00b0C -25u00b0C ).
u00b7u00a0u00a0u00a0 Keep zafirlukast tablets dry.
u00b7u00a0u00a0u00a0 Keep zafirlukast in a tight closed container and keep zafirlukast out of the light.
u00b7 u00a0u00a0u00a0u00a0Keep zafirlukast and all medicines out of the reach of children.
General information about the safe and effective use of Zafirlukast.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.u00a0 Do not use zafirlukast for a condition for which it was not prescribed. Do not give zafirlukast to other people, even if they have the same symptoms thatu00a0 you have. It may harm them.
This Patient Information leaflet summarizes the most important information about zafirlukast. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zafirlukast that is written for healthcare professionals.
For more information, go to www.parpharm.com, or call 1-800-828-9393.
What are the ingredients in Zafirlukast?
Active ingredient
Inactive ingredients
What do Zafirlukast tablets look like?
u00b7the 10 mg tablet is white and round with u201cPu201d marked on one side, and u201c10u201d on the other.
u00b7u00a0u00a0u00a0u00a0the 20 mg tablet is white and round with u201cPu201d marked on one side, and u201c20u201d on the other.
ACCOLATE is a registered trademark of Par Pharmaceutical, Inc.
Manufactured by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.
Distributed By:
MAJORu00ae PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Refer to package label for Distributor's NDC Number
R12/16

Zafirlukast Tablets
20 mg
30 Tablets

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Zafirlukast (Zafirlukast)

Trade Name : Zafirlukast

TABLET, 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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About GNH

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Zafirlukast (Zafirlukast)

Trade Name : Zafirlukast

TABLET, 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)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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