Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOG | HALCINONIDE | 0.1% | 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 |
---|---|---|---|---|---|---|---|
06/15/1977 | 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 |
---|---|---|---|---|---|
09/29/2004 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17824s024ltr.pdf | |
06/29/1990 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/27/1989 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/03/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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07/29/1985 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1985 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/13/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/12/1983 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/26/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/02/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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04/15/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/13/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/19/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/17/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/10/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/09/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/12/1978 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/08/1978 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/09/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/24/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/24/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/24/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/29/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17824s024lbl.pdf |