BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Farmers Insurance
Express Scripts

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204139

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NDA 204139 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Amneal Pharms, Aurobindo Pharma Ltd, Daewoong Pharm Co, Gland Pharma Ltd, Hospira Inc, Par Sterile Products, Sandoz, Savior Lifetec Corp, and B Braun Medical Inc, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the MEROPENEM profile page.

The generic ingredient in MEROPENEM is meropenem. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 204139
Applicant:Par Sterile Products
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204139
Suppliers and Packaging for NDA: 204139
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 204139 ANDA Par Pharmaceutical, Inc. 42023-191 N 42023-191-10
MEROPENEM meropenem INJECTABLE;INJECTION 204139 ANDA Par Pharmaceutical, Inc. 42023-192 N 42023-192-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Jun 9, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Jun 9, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Cantor Fitzgerald
Fish and Richardson
Boehringer Ingelheim

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