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Details for New Drug Application (NDA): 091201

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NDA 091201 describes MEROPENEM, which is a drug marketed by Sandoz, Acs Dobfar, Par Sterile Products, Hospira Inc, Gland Pharma Ltd, Daewoong Pharm Co, Amneal Pharms, Savior Lifetec Corp, and B Braun Medical Inc, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the MEROPENEM profile page.

The generic ingredient in MEROPENEM is meropenem. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the meropenem profile page.

Summary for NDA: 091201

Therapeutic Class:Antibacterials

Pharmacology for NDA: 091201


Suppliers and Packaging for NDA: 091201

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 091201 ANDA Sandoz Inc 0781-3265 0781-3265-95 10 VIAL, GLASS in 1 CARTON (0781-3265-95) > 10 mL in 1 VIAL, GLASS (0781-3265-80)
INJECTABLE;INJECTION 091201 ANDA Sandoz Inc 0781-3267 0781-3267-95 10 VIAL, GLASS in 1 CARTON (0781-3267-95) > 20 mL in 1 VIAL, GLASS (0781-3267-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Mar 29, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Mar 29, 2011TE:APRLD:No

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