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Generated: May 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206141

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NDA 206141 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Aurobindo Pharma Ltd, Daewoong Pharm Co, Gland Pharma Ltd, Hospira Inc, Sandoz, Savior Lifetec Corp, and B Braun Medical Inc, and is included in ten NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 206141
Tradename:MEROPENEM
Applicant:Gland Pharma Ltd
Ingredient:meropenem
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206141
Suppliers and Packaging for NDA: 206141
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 206141 ANDA Gland Pharma Limited 68083-146 68083-146-10 10 VIAL in 1 CARTON (68083-146-10) > 20 mL in 1 VIAL
MEROPENEM meropenem INJECTABLE;INJECTION 206141 ANDA Gland Pharma Limited 68083-147 68083-147-10 10 VIAL in 1 CARTON (68083-147-10) > 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Jun 8, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Jun 8, 2016TE:APRLD:No

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