Drugs@FDA: FDA Approved Drug Products

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

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

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

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