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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020208
Company: BAUSCH

Products on NDA 020208

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020208

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/1992	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
04/17/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/28/1997	SUPPL-7	Labeling		Label is not available on this site.
05/16/1997	SUPPL-6	Efficacy-New Dosing Regimen		Label is not available on this site.
02/07/1995	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/30/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/06/1995	SUPPL-3	Labeling		Label is not available on this site.
07/26/1993	SUPPL-2	Labeling		Label is not available on this site.
03/17/1993	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 020208

METROGEL-VAGINAL

GEL;VAGINAL; 0.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROGEL-VAGINAL	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	Yes	AB	020208	BAUSCH
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	216323	COSETTE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	215610	ENCUBE
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	215794	GLENMARK PHARMS LTD
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	211786	PADAGIS ISRAEL
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	No	AB	213648	SOLARIS PHARMA CORP

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