Details for New Drug Application (NDA): 050630

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NDA 050630 describes PRIMAXIN, which is a drug marketed by Merck and is included in three NDAs. It is available from one supplier. Additional details are available on the PRIMAXIN profile page.

The generic ingredient in PRIMAXIN 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 050630

Tradename:	PRIMAXIN
Applicant:	Merck
Ingredient:	cilastatin sodium; imipenem
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAMUSCULAR			Strength	EQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:	Dec 14, 1990	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAMUSCULAR			Strength	EQ 750MG BASE/VIAL;750MG/VIAL
Approval Date:	Dec 14, 1990	TE:		RLD:	No

Expired US Patents for NDA 050630

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990	⤷ Sign Up	⤷ Sign Up
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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