Details for New Drug Application (NDA): 216441
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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 216441
Tradename: | FAMOTIDINE |
Applicant: | Zydus Pharms |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216441
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 216441
Suppliers and Packaging for NDA: 216441
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | TABLET;ORAL | 216441 | ANDA | ST. MARY'S MEDICAL PARK PHARMACY | 60760-736 | 60760-736-07 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-736-07) |
FAMOTIDINE | famotidine | TABLET;ORAL | 216441 | ANDA | ST. MARY'S MEDICAL PARK PHARMACY | 60760-736 | 60760-736-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-736-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 3, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jun 3, 2022 | TE: | AB | RLD: | No |
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