Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019968
Company: SUN PHARM INDS INC
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ULTRAVATE | HALOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | Yes | No |
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. |
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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 |