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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091007


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NDA 091007 describes IMIPENEM AND CILASTATIN, which is a drug marketed by Acs Dobfar, Hospira Inc, and Hq Spclt Pharma, and is included in four NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 091007
Tradename:IMIPENEM AND CILASTATIN
Applicant:Hospira Inc
Ingredient:cilastatin sodium; imipenem
Patents:0

Profile for product number 001

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

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