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Serving 500+ biopharmaceutical companies globally:

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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075813

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NDA 075813 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-three suppliers are listed for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 075813

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

UBS
Cipla
AstraZeneca
Cerilliant
US Army
Dow
Boehringer Ingelheim
Moodys
QuintilesIMS
Fish and Richardson

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