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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204854

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NDA 204854 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 204854

Tradename:	MEROPENEM
Applicant:	Daewoong Pharm Co
Ingredient:	meropenem
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Dec 18, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	Dec 18, 2015	TE:		RLD:	No

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