Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020209
Company: FOUGERA PHARMS
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
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
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English