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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077197
Company: FOUGERA PHARMS

Products on ANDA 077197

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077197LTR.pdf

Therapeutic Equivalents for ANDA 077197

METRONIDAZOLE

LOTION;TOPICAL; 0.75%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METROLOTION	METRONIDAZOLE	0.75%	LOTION;TOPICAL	Prescription	Yes	AB	020901	GALDERMA LABS LP
METRONIDAZOLE	METRONIDAZOLE	0.75%	LOTION;TOPICAL	Prescription	No	AB	077197	FOUGERA PHARMS

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