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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020209
Company: ANI PHARMS

Products on NDA 020209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXISTAT	OXICONAZOLE NITRATE	EQ 1% BASE	LOTION;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1992	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020209Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020209Orig1s014ltr.pdf
08/19/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/03/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/26/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/23/2004	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19828slr009,20209slr005ltr.pdf
08/08/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/21/1993	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020209

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020209Orig1s014lbl.pdf
01/23/2004	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf

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