Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076043
Company: SUN PHARMA CANADA

Products on ANDA 076043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERCONAZOLE	TERCONAZOLE	0.4%	CREAM;VAGINAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/20/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076043

TERCONAZOLE

CREAM;VAGINAL; 0.4%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TERCONAZOLE	TERCONAZOLE	0.4%	CREAM;VAGINAL	Prescription	No	AB	076712	FOUGERA PHARMS
TERCONAZOLE	TERCONAZOLE	0.4%	CREAM;VAGINAL	Prescription	No	AB	076043	SUN PHARMA CANADA