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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091404

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NDA 091404 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 091404

Tradename:	MEROPENEM
Applicant:	Acs Dobfar
Ingredient:	meropenem
Patents:	0

Pharmacology for NDA: 091404

Suppliers and Packaging for NDA: 091404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-0222	0409-0222-10	10 VIAL in 1 CARTON (0409-0222-10) / 10 mL in 1 VIAL (0409-0222-01)
MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-1390	0409-1390-51	10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Oct 26, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	Oct 26, 2011	TE:	AP	RLD:	No

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