Details for New Drug Application (NDA): 078641
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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 078641
Tradename: | FAMOTIDINE |
Applicant: | Mylan Labs Ltd |
Ingredient: | famotidine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078641
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078641
Suppliers and Packaging for NDA: 078641
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FAMOTIDINE | famotidine | INJECTABLE;INJECTION | 078641 | ANDA | Mylan Institutional LLC | 67457-448 | 67457-448-43 | 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00) |
FAMOTIDINE | famotidine | INJECTABLE;INJECTION | 078641 | ANDA | Mylan Institutional LLC | 67457-457 | 67457-457-20 | 10 VIAL in 1 CARTON (67457-457-20) / 20 mL in 1 VIAL (67457-457-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Jun 25, 2008 | TE: | AP | RLD: | No |
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