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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Federal Trade Commission

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206086

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NDA 206086 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 206086
Applicant:Savior Lifetec Corp
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 206086
Suppliers and Packaging for NDA: 206086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 206086 ANDA Sandoz Inc 0781-3000 N 0781-3000-95
MEROPENEM meropenem INJECTABLE;INJECTION 206086 ANDA Sandoz Inc 0781-3000 N 0781-3000-96

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Apr 19, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Apr 19, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts

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