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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
Argus Health

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075591

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NDA 075591 describes FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, which is a drug marketed by Abbvie and Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER profile page.

The generic ingredient in FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER is famotidine. There are eighteen drug master file entries for this compound. One hundred and sixteen suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075591
Applicant:Baxter Hlthcare
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075591
Medical Subject Heading (MeSH) Categories for 075591
Suppliers and Packaging for NDA: 075591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER famotidine INJECTABLE;INJECTION 075591 ANDA Baxter Healthcare Corporation 0338-5197 N 0338-5197-41

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:May 10, 2001TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Harvard Business School
US Army
Chinese Patent Office

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