Details for New Drug Application (NDA): 075488
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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 075488
Tradename: | FAMOTIDINE |
Applicant: | Hikma |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075488
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075488
Suppliers and Packaging for NDA: 075488
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | INJECTABLE;INJECTION | 075488 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6021 | 0641-6021-10 | 10 VIAL in 1 CARTON (0641-6021-10) / 20 mL in 1 VIAL (0641-6021-01) |
FAMOTIDINE | famotidine | INJECTABLE;INJECTION | 075488 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6023 | 0641-6023-10 | 10 VIAL in 1 CARTON (0641-6023-10) / 4 mL in 1 VIAL (0641-6023-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Apr 16, 2001 | TE: | AP | RLD: | No |
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