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Details for New Drug Application (NDA): 206141

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NDA 206141 describes MEROPENEM, which is a drug marketed by Sandoz, Acs Dobfar, Par Sterile Products, Hospira Inc, Gland Pharma Ltd, Daewoong Pharm Co, Amneal Pharms, Savior Lifetec Corp, and B Braun Medical Inc, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the MEROPENEM profile page.

The generic ingredient in MEROPENEM is meropenem. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for NDA: 206141

Gland Pharma Ltd
Therapeutic Class:Antibacterials

Pharmacology for NDA: 206141


Suppliers and Packaging for NDA: 206141

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

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

Summary for product number 002

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

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