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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
US Army

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090825

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NDA 090825 describes IMIPENEM AND CILASTATIN, which is a drug marketed by Acs Dobfar and Hospira Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the IMIPENEM AND CILASTATIN profile page.

The generic ingredient in IMIPENEM AND CILASTATIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 090825
Applicant:Hospira Inc
Ingredient:cilastatin sodium; imipenem
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090825
Mechanism of ActionDipeptidase Inhibitors
Suppliers and Packaging for NDA: 090825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPENEM AND CILASTATIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 090825 ANDA Hospira, Inc. 0409-3507 N 0409-3507-01
IMIPENEM AND CILASTATIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 090825 ANDA Hospira, Inc. 0409-3508 N 0409-3508-01

Profile for product number 001

Approval Date:Nov 16, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Nov 16, 2011TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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US Department of Justice

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