Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012041
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KENALOG-10 | TRIAMCINOLONE ACETONIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/04/1960 | 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 |
|---|---|---|---|---|---|
| 08/14/2024 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012041Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/012041Orig1s052ltr.pdf | |
| 06/05/2024 | SUPPL-51 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012041s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/012041Orig1s051ltr.pdf | |
| 06/22/2018 | SUPPL-45 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s045ltr.pdf | |
| 03/29/2018 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012041Orig1s044ltr.pdf | |
| 10/26/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901Orig1s042ltr.pdf | |
| 07/15/2011 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf | |
| 06/16/2011 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/012041Orig1s038.pdf | |
| 01/28/2010 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,014901s037ltr.pdf | |
| 06/15/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/2006 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012041s033ltr.pdf | |
| 02/03/1998 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1995 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1993 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/30/1993 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/25/1991 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1991 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/19/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1981 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1979 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1977 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/28/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/14/2024 | SUPPL-52 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012041Orig1s052lbl.pdf | |
| 06/05/2024 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012041s051lbl.pdf | |
| 06/05/2024 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012041s051lbl.pdf | |
| 06/22/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf | |
| 06/22/2018 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s045lbl.pdf | |
| 03/29/2018 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012041s044lbl.pdf | |
| 07/03/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf | |
| 07/15/2011 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf | |
| 06/16/2011 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf | |
| 01/28/2010 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf | |
| 11/20/2006 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf |
KENALOG-10
INJECTABLE;INJECTION; 10MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KENALOG-10 | TRIAMCINOLONE ACETONIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 012041 | APOTHECON |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 218773 | DR REDDYS |