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Generated: November 13, 2018

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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. One hundred and fifteen suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075813
Tradename:FAMOTIDINE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:famotidine
Patents:0
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 APP Pharmaceuticals, LLC 63323-739 63323-739-12 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) > 2 mL in 1 VIAL, SINGLE-DOSE
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075813 ANDA APP Pharmaceuticals, LLC 63323-739 63323-739-16 25 VIAL, SINGLE-USE in 1 TRAY (63323-739-16) > 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

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

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