Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019967
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRAVATE HALOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None Yes No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
12/27/1990 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
12/09/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/24/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/29/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/02/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019967s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019967s015,019968s011ltr.pdf
09/17/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19967s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19967s010ltr.pdf
10/04/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019967s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19967slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019967_S004_ULTRAVATE CREAM.pdf
12/30/1991 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1993 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-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019967s015lbl.pdf
09/17/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19967s010lbl.pdf
04/02/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019967s004lbl.pdf

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