Details for New Drug Application (NDA): 090283
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The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 090283
Tradename: | FAMOTIDINE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090283
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090283
Suppliers and Packaging for NDA: 090283
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | TABLET;ORAL | 090283 | ANDA | AMERISOURCE BERGEN | 46122-168 | 46122-168-78 | 100 TABLET, FILM COATED in 1 BOTTLE (46122-168-78) |
FAMOTIDINE | famotidine | TABLET;ORAL | 090283 | ANDA | Premier Value | 68016-008 | 68016-008-01 | 25 TABLET, FILM COATED in 1 BOTTLE (68016-008-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 17, 2009 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 17, 2009 | TE: | RLD: | No |
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