Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076005
Company: TARO

Products on ANDA 076005

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076005

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole Nirate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76005_Econazole Nirate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076005_econazole-nirate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/15/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 076005

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole Nirate_Prntlbl.pdf

Therapeutic Equivalents for ANDA 076005

ECONAZOLE NITRATE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM;TOPICAL	Prescription	No	AB	076479	PADAGIS ISRAEL
ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM;TOPICAL	Prescription	No	AB	076005	TARO