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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019828
Company: FOUGERA PHARMS

Products on NDA 019828

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXISTAT	OXICONAZOLE NITRATE	EQ 1% BASE	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019828

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1988	ORIG-1	Approval	Type 1 - New Molecular Entity	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
01/23/2004	SUPPL-9	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-8	Manufacturing (CMC)		Label is not available on this site.
08/18/1997	SUPPL-7	Efficacy-New Patient Population		Label is not available on this site.
06/07/1994	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/30/1992	SUPPL-5	Efficacy-New Indication		Label is not available on this site.
08/18/1997	SUPPL-3	Efficacy-New Indication		Label is not available on this site.
11/28/1989	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/1989	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019828

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2004	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf

Therapeutic Equivalents for NDA 019828

OXISTAT

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	TARO
OXISTAT	OXICONAZOLE NITRATE	EQ 1% BASE	CREAM;TOPICAL	Prescription	Yes	AB	019828	FOUGERA PHARMS

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