Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076408
Company: FOUGERA PHARMS

Products on ANDA 076408

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2004	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76408ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076408_ORIGINAL APPROVAL_PACKAGE.pdf

Therapeutic Equivalents for ANDA 076408

METRONIDAZOLE

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