Details for New Drug Application (NDA): 075486
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NDA 075486 describes FAMOTIDINE PRESERVATIVE FREE, which is a drug marketed by Apothecon, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Abbvie, and Baxter Hlthcare, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the FAMOTIDINE PRESERVATIVE FREE profile page.
The generic ingredient in FAMOTIDINE PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-four suppliers are listed for this compound. Additional details are available on the famotidine profile page.
The generic ingredient in FAMOTIDINE PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-four suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075486
| Tradename: | FAMOTIDINE PRESERVATIVE FREE |
| Applicant: | Hikma |
| Ingredient: | famotidine |
| Patents: | 0 |
Pharmacology for NDA: 075486
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075486
Suppliers and Packaging for NDA: 075486
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075486 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6022 | 0641-6022-25 | 25 VIAL in 1 CARTON (0641-6022-25) / 2 mL in 1 VIAL (0641-6022-01) |
| FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075486 | ANDA | Medical Purchasing Solutions, LLC | 71872-7235 | 71872-7235-1 | 1 VIAL in 1 BAG (71872-7235-1) / 2 mL in 1 VIAL |
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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