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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215212

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NDA 215212 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 Inc, and is included in fourteen NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for 215212

Tradename:	MEROPENEM
Applicant:	Hq Spclt Pharma
Ingredient:	meropenem
Patents:	0

Pharmacology for NDA: 215212

Suppliers and Packaging for NDA: 215212

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEROPENEM	meropenem	POWDER;INTRAVENOUS	215212	NDA	WG Critical Care, LLC	44567-402	44567-402-06	6 VIAL in 1 CARTON (44567-402-06) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-402-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	2GM/VIAL
Approval Date:	Jul 26, 2023	TE:		RLD:	Yes

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