Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020531
Company: GALDERMA LABS LP

Products on NDA 020531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METROCREAM	METRONIDAZOLE	0.75%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/1995	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/30/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 020531

METROCREAM

CREAM;TOPICAL; 0.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROCREAM	METRONIDAZOLE	0.75%	CREAM;TOPICAL	Prescription	Yes	AB	020531	GALDERMA LABS LP
METRONIDAZOLE	METRONIDAZOLE	0.75%	CREAM;TOPICAL	Prescription	No	AB	077549	COSETTE
METRONIDAZOLE	METRONIDAZOLE	0.75%	CREAM;TOPICAL	Prescription	No	AB	076408	FOUGERA PHARMS
METRONIDAZOLE	METRONIDAZOLE	0.75%	CREAM;TOPICAL	Prescription	No	AB	217128	ZYDUS LIFESCIENCES