Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
WESTCORT | HYDROCORTISONE VALERATE | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/17/1978 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
03/24/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17950slr021ltr.pdf | |
11/29/1991 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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10/04/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/27/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/13/1985 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/03/1985 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/1984 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/05/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/06/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/08/1982 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/27/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/08/1982 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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05/14/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/10/1980 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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04/10/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/11/1978 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/03/1979 | 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 |
---|---|---|---|---|---|
03/24/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.pdf |