Details for New Drug Application (NDA): 075622
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NDA 075622 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 seven 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-two 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-two suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075622
| Tradename: | FAMOTIDINE PRESERVATIVE FREE |
| Applicant: | Sagent |
| Ingredient: | famotidine |
| Patents: | 0 |
Pharmacology for NDA: 075622
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 075622
Suppliers and Packaging for NDA: 075622
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075622 | ANDA | Sagent Pharmaceuticals | 25021-753 | 25021-753-02 | 25 VIAL in 1 CARTON (25021-753-02) / 2 mL in 1 VIAL |
| FAMOTIDINE PRESERVATIVE FREE | famotidine | INJECTABLE;INJECTION | 075622 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-751 | 70860-751-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70860-751-02) / 2 mL in 1 VIAL, SINGLE-DOSE (70860-751-41) |
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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