Details for New Drug Application (NDA): 201695
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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 201695
Tradename: | FAMOTIDINE |
Applicant: | Novel Labs Inc |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201695
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 201695
Suppliers and Packaging for NDA: 201695
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 201695 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-500 | 43386-500-11 | 50 mL in 1 BOTTLE (43386-500-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/5ML | ||||
Approval Date: | Dec 17, 2012 | TE: | AB | RLD: | No |
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