Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205076
Company: SUN PHARMA CANADA

Products on ANDA 205076

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205076Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205076Orig1s000ltr.pdf

Labels for ANDA 205076

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205076Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205076

OXICONAZOLE NITRATE

CREAM;TOPICAL; EQ 1% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXICONAZOLE NITRATE	OXICONAZOLE NITRATE	EQ 1% BASE	CREAM;TOPICAL	Prescription	No	AB	205076	SUN PHARMA CANADA
OXISTAT	OXICONAZOLE NITRATE	EQ 1% BASE	CREAM;TOPICAL	Prescription	Yes	AB	019828	FOUGERA PHARMS