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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205883


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NDA 205883 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 205883
Tradename:MEROPENEM
Applicant:Amneal Pharms
Ingredient:meropenem
Patents:0
Pharmacology for NDA: 205883
Suppliers and Packaging for NDA: 205883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 205883 ANDA BluePoint Laboratories 68001-323 68001-323-31 10 VIAL, GLASS in 1 CARTON (68001-323-31) / 20 mL in 1 VIAL, GLASS (68001-323-29)
MEROPENEM meropenem INJECTABLE;INJECTION 205883 ANDA BluePoint Laboratories 68001-324 68001-324-57 10 VIAL, GLASS in 1 CARTON (68001-324-57) / 30 mL in 1 VIAL, GLASS (68001-324-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Apr 12, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Apr 12, 2016TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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