Details for New Drug Application (NDA): 050587

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NDA 050587 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 050587

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

Pharmacology for NDA: 050587

Mechanism of Action	Dipeptidase Inhibitors

Suppliers and Packaging for NDA: 050587

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587	NDA	Merck Sharp & Dohme LLC	0006-3516	0006-3516-59	25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 250MG BASE/VIAL;250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 26, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:	Nov 26, 1985	TE:	AP	RLD:	Yes

Expired US Patents for NDA 050587

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-001	Nov 26, 1985	⤷ Subscribe	⤷ Subscribe
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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