Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019968
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRAVATE HALOBETASOL PROPIONATE 0.05% OINTMENT;TOPICAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/17/1990 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
05/17/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/02/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf
09/17/2004 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19968s007ltr.pdf
07/12/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1991 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/02/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf
09/17/2004 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf

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