Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019737
Company: GALDERMA LABS LP

Products on NDA 019737

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/1988	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2002	SUPPL-7	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19737s007ltr.pdf
08/21/1995	SUPPL-6	Labeling		Label is not available on this site.
03/24/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/20/1989	SUPPL-3	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/19/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/02/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 019737

METROGEL

GEL;TOPICAL; 0.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROGEL	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	Yes	AB	019737	GALDERMA LABS LP
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	No	AB	078178	COSETTE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	No	AB	077547	ENCUBE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	No	AB	077018	FOUGERA PHARMS
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	No	AB	077819	TARO