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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 075813

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NDA 075813 describes FAMOTIDINE PRESERVATIVE FREE, which is a drug marketed by Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Abbvie, and Baxter Hlthcare, and is included in twelve NDAs. It is available from four 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. Eighty-seven suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075813
Applicant:Fresenius Kabi Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 075813
Medical Subject Heading (MeSH) Categories for 075813
Suppliers and Packaging for NDA: 075813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075813 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1375 51662-1375-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1)
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075813 ANDA Fresenius Kabi USA, LLC 63323-739 63323-739-12 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) > 2 mL in 1 VIAL, SINGLE-DOSE (63323-739-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 16, 2001TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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