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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216154

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NDA 216154 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 216154

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

Pharmacology for NDA: 216154

Suppliers and Packaging for NDA: 216154

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEROPENEM	meropenem	INJECTABLE;INJECTION	216154	ANDA	ARMAS PHARMACEUTICALS INC	72485-411	72485-411-01	1 VIAL in 1 CARTON (72485-411-01) / 20 mL in 1 VIAL
MEROPENEM	meropenem	INJECTABLE;INJECTION	216154	ANDA	ARMAS PHARMACEUTICALS INC	72485-411	72485-411-10	10 VIAL in 1 CARTON (72485-411-10) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Aug 18, 2022	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	Aug 18, 2022	TE:	AP	RLD:	No

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