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Serving leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Colorcon
Cantor Fitzgerald
Novartis
Citi
Medtronic
Dow
US Department of Justice
McKesson

Generated: January 18, 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-one 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
Tradename:MEROPENEM
Applicant:Par Sterile Products
Ingredient:meropenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204139
Ingredient-typeCarbapenems
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 42023-191-10 10 VIAL in 1 CARTON (42023-191-10) > 20 mL in 1 VIAL (42023-191-01)
MEROPENEM meropenem INJECTABLE;INJECTION 204139 ANDA Par Pharmaceutical, Inc. 42023-192 42023-192-10 10 VIAL in 1 CARTON (42023-192-10) > 30 mL in 1 VIAL (42023-192-01)

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 leading biopharmaceutical companies globally:

UBS
Covington
Accenture
McKesson
Merck
Fish and Richardson
Chinese Patent Office
Cantor Fitzgerald
Queensland Health

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