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Last Updated: March 29, 2024

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 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 thirty-five 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 075622
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 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:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 16, 2001TE:APRLD:No

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