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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206086


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NDA 206086 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 206086
Tradename:MEROPENEM
Applicant:Savior Lifetec Corp
Ingredient:meropenem
Patents:0
Pharmacology for NDA: 206086
Suppliers and Packaging for NDA: 206086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 206086 ANDA Sandoz Inc 0781-3000 0781-3000-95 10 VIAL in 1 CARTON (0781-3000-95) / 20 mL in 1 VIAL (0781-3000-94)
MEROPENEM meropenem INJECTABLE;INJECTION 206086 ANDA Sandoz Inc 0781-3000 0781-3000-96 25 VIAL in 1 CARTON (0781-3000-96) / 20 mL in 1 VIAL (0781-3000-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Apr 19, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Apr 19, 2016TE:APRLD:No

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