Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021735
Company: FOUGERA PHARMS INC

Products on NDA 021735

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERCONAZOLE	TERCONAZOLE	0.8%	CREAM;VAGINAL	Prescription	BX	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021735

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2004	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21735lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21735ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021735s000_TerconazoleTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/30/2010	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021735s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021735s004ltr.pdf

Labels for NDA 021735

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/30/2010	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021735s004lbl.pdf
10/01/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21735lbl.pdf

Therapeutic Equivalents for NDA 021735

TERCONAZOLE

There are no Therapeutic Equivalents.