Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050637
Company: PHARMACIA AND UPJOHN

Products on NDA 050637

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEFAZONE	CEFMETAZOLE SODIUM	EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ZEFAZONE	CEFMETAZOLE SODIUM	EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050637

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/1989	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/1993	SUPPL-8	Labeling		Label is not available on this site.
09/17/2001	SUPPL-7	Labeling		Label is not available on this site.
09/17/2001	SUPPL-6	Efficacy-New Dosing Regimen		Label is not available on this site.
12/08/1993	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/30/1993	SUPPL-4	Labeling		Label is not available on this site.
09/17/2001	SUPPL-3	Efficacy-New Indication		Label is not available on this site.
09/29/1992	SUPPL-1	Efficacy-New Indication		Label is not available on this site.