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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091404


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NDA 091404 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 091404
Tradename:MEROPENEM
Applicant:Acs Dobfar
Ingredient:meropenem
Patents:0
Pharmacology for NDA: 091404
Suppliers and Packaging for NDA: 091404
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 091404 ANDA Hospira, Inc. 0409-0222 0409-0222-10 10 VIAL in 1 CARTON (0409-0222-10) / 10 mL in 1 VIAL (0409-0222-01)
MEROPENEM meropenem INJECTABLE;INJECTION 091404 ANDA Hospira, Inc. 0409-1390 0409-1390-51 10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No

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