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Generated: May 25, 2017

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Details for New Drug Application (NDA): 078642

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NDA 078642 describes FAMOTIDINE PRESERVATIVE FREE, which is a drug marketed by Apothecon, Fresenius Kabi Usa, Athenex Inc, Apotex Inc, Mylan Labs Ltd, Hospira, West-ward Pharms Int, Eurohlth Intl Sarl, Abbvie, and Baxter Hlthcare, and is included in twelve NDAs. It is available from five 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 twenty-two suppliers are listed for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 078642

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078642

Suppliers and Packaging for NDA: 078642

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 078642 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0121 0069-0121-02 25 VIAL, SINGLE-DOSE in 1 CARTON (0069-0121-02) > 2 mL in 1 VIAL, SINGLE-DOSE (0069-0121-01)
INJECTABLE;INJECTION 078642 ANDA Mylan Institutional LLC 67457-433 67457-433-22 25 VIAL in 1 CARTON (67457-433-22) > 2 mL in 1 VIAL (67457-433-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 25, 2008TE:APRLD:No

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