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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075953
Company: TARO

Products on ANDA 075953

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERCONAZOLE	TERCONAZOLE	0.8%	CREAM;VAGINAL	Prescription	BX	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075953_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/25/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075953

TERCONAZOLE

There are no Therapeutic Equivalents.

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