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% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 05/04/1977 | 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 |
|---|---|---|---|---|---|
| 03/18/2020 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017823Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017823Orig1s024ltr.pdf | |
| 09/29/2004 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17823s023ltr.pdf | |
| 10/08/1996 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1989 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/30/1981 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/12/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1980 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/12/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-3 | 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 |
|---|---|---|---|---|---|
| 03/18/2020 | SUPPL-24 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017823Orig1s024lbl.pdf | |
| 09/29/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17823s023lbl.pdf |