Details for New Drug Application (NDA): 075718
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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 075718
Tradename: | FAMOTIDINE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | famotidine |
Patents: | 0 |
Pharmacology for NDA: 075718
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075718
Suppliers and Packaging for NDA: 075718
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | TABLET;ORAL | 075718 | ANDA | Major Pharmaceuticals | 0904-7193 | 0904-7193-06 | 50 BLISTER PACK in 1 CARTON (0904-7193-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
FAMOTIDINE | famotidine | TABLET;ORAL | 075718 | ANDA | Major Pharmaceuticals | 0904-7193 | 0904-7193-61 | 100 BLISTER PACK in 1 CARTON (0904-7193-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 16, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 16, 2001 | TE: | AB | RLD: | No |
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