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% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/27/1974 | 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 |
|---|---|---|---|---|---|
| 04/02/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2009 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017556s038ltr.pdf | |
| 09/29/2004 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17556s034ltr.pdf | |
| 06/29/1990 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1989 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1989 | SUPPL-31 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1986 | SUPPL-28 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1985 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/1984 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/26/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/20/1980 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/24/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/02/1979 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/07/1978 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1978 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/09/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/07/1975 | SUPPL-3 | 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 |
|---|---|---|---|---|---|
| 06/10/2009 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf | |
| 06/10/2009 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017556s038lbl.pdf | |
| 09/29/2004 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17556s034lbl.pdf |
HALOG
CREAM;TOPICAL; 0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HALCINONIDE | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 214723 | CHARTWELL RX |
| HALCINONIDE | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 211027 | MYLAN |
| HALOG | HALCINONIDE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 017556 | SUN PHARM INDS INC |