Details for New Drug Application (NDA): 206531
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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 206531
Tradename: | FAMOTIDINE |
Applicant: | Aurobindo Pharma |
Ingredient: | famotidine |
Patents: | 0 |
Pharmacology for NDA: 206531
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 206531
Suppliers and Packaging for NDA: 206531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | TABLET;ORAL | 206531 | ANDA | WALGREEN CO. | 0363-1899 | 0363-1899-14 | 1 BOTTLE in 1 CARTON (0363-1899-14) / 50 TABLET, FILM COATED in 1 BOTTLE |
FAMOTIDINE | famotidine | TABLET;ORAL | 206531 | ANDA | WALGREEN CO. | 0363-1899 | 0363-1899-24 | 1 BOTTLE in 1 CARTON (0363-1899-24) / 90 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 26, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 26, 2016 | TE: | RLD: | No |
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