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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091201

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NDA 091201 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for 091201

Tradename:	MEROPENEM
Applicant:	Sandoz
Ingredient:	meropenem
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Mar 29, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	Mar 29, 2011	TE:		RLD:	No

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