Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076075
Company: CHARTWELL RX

Products on ANDA 076075

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076075

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/anda/2002/76075_Econazole%20Nitrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76075_Econazole%20Nitrate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075075_econazole.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/16/2005	SUPPL-5	Labeling		Label is not available on this site.

Labels for ANDA 076075

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/anda/2002/76075_Econazole%20Nitrate_Prntlbl.pdf