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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ULTRAVATE HALOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT;TOPICAL Discontinued None Yes No
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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