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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 050706

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NDA 050706 describes MERREM, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the MERREM profile page.

The generic ingredient in MERREM is meropenem. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 050706
Formulation / Manufacturing:see details
Pharmacology for NDA: 050706
Suppliers and Packaging for NDA: 050706
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MERREM meropenem INJECTABLE;INJECTION 050706 NDA Pfizer Laboratories Div Pfizer Inc 0069-0313 0069-0313-10 10 VIAL in 1 CARTON (0069-0313-10) > 20 mL in 1 VIAL (0069-0313-01)
MERREM meropenem INJECTABLE;INJECTION 050706 NDA Pfizer Laboratories Div Pfizer Inc 0069-0314 0069-0314-10 10 VIAL in 1 CARTON (0069-0314-10) > 30 mL in 1 VIAL (0069-0314-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Jun 21, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Jun 21, 1996TE:APRLD:Yes

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