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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090577

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NDA 090577 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 090577
Tradename:IMIPENEM AND CILASTATIN
Applicant:Acs Dobfar
Ingredient:cilastatin sodium; imipenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090577
Ingredient-typeCarbapenems
Mechanism of ActionDipeptidase Inhibitors
Suppliers and Packaging for NDA: 090577
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPENEM AND CILASTATIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 090577 ANDA Cardinal Health 55154-9389 E 55154-9389-5
IMIPENEM AND CILASTATIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 090577 ANDA Fresenius Kabi USA, LLC 63323-322 E 63323-322-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Dec 21, 2011TE:APRLD:No

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