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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219084

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NDA 219084 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Brooks Steriscience, Daewoong Pharm Co, Eugia Pharma, Gland, Hospira Inc, Hq Spclt Pharma, Qilu, Sandoz, Savior Lifetec Corp, and B Braun Medical, and is included in fifteen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for 219084

Tradename:	MEROPENEM
Applicant:	Brooks Steriscience
Ingredient:	meropenem
Patents:	0

Pharmacology for NDA: 219084

Suppliers and Packaging for NDA: 219084

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEROPENEM	meropenem	POWDER;INTRAVENOUS	219084	ANDA	Mylan Institutional LLC	72078-081	72078-081-06	6 INJECTION in 1 CARTON (72078-081-06)
MEROPENEM	meropenem	POWDER;INTRAVENOUS	219084	ANDA	BROOKS STERISCIENCE LIMITED	81962-002	81962-002-08	6 INJECTION in 1 CARTON (81962-002-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	2GM/VIAL
Approval Date:	Jun 23, 2025	TE:	AP	RLD:	No

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