Details for New Drug Application (NDA): 091020
✉ 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 091020
Tradename: | FAMOTIDINE |
Applicant: | Navinta Llc |
Ingredient: | famotidine |
Patents: | 0 |
Pharmacology for NDA: 091020
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091020
Suppliers and Packaging for NDA: 091020
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 091020 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-444 | 68382-444-05 | 50 mL in 1 BOTTLE, PLASTIC (68382-444-05) |
FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 091020 | ANDA | Navinta LLC | 68475-400 | 68475-400-01 | 50 mL in 1 BOTTLE, PLASTIC (68475-400-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/5ML | ||||
Approval Date: | May 27, 2010 | TE: | AB | RLD: | No |
Complete Access Available with Subscription