Details for New Drug Application (NDA): 216427
✉ Email this page to a colleague
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 216427
Tradename: | FAMOTIDINE |
Applicant: | Amneals Pharms |
Ingredient: | famotidine |
Patents: | 0 |
Pharmacology for NDA: 216427
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 216427
Suppliers and Packaging for NDA: 216427
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 216427 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2090 | 60219-2090-4 | 50 mL in 1 BOTTLE (60219-2090-4) |
FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 216427 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2090 | 69238-2090-4 | 50 mL in 1 BOTTLE (69238-2090-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/5ML | ||||
Approval Date: | Aug 4, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription