Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077018
Company: FOUGERA PHARMS

Products on ANDA 077018

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077018

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077018s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077018

METRONIDAZOLE

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