Details for New Drug Application (NDA): 090577

NDA 090577 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 090577

Tradename:	IMIPENEM AND CILASTATIN
Applicant:	Acs Dobfar
Ingredient:	cilastatin sodium; imipenem
Patents:	0

Pharmacology for NDA: 090577

Mechanism of Action

Dipeptidase 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	Fresenius Kabi USA, LLC	63323-322	63323-322-25	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-01)
IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	090577	ANDA	Fresenius Kabi USA, LLC	63323-322	63323-322-93	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-93) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:	Dec 21, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:	Dec 21, 2011	TE:	AP	RLD:	No

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