Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014901
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AB | Yes | Yes |
| KENALOG-80 | TRIAMCINOLONE ACETONIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/1965 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 04/12/2019 | SUPPL-47 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/014901Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/014901Orig1s047ltr.pdf | ||
| 06/22/2018 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf | |
| 03/29/2018 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014901Orig1s044ltr.pdf | |
| 10/26/2015 | SUPPL-43 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/014901Orig1s043.pdf |
| 07/03/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.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/2011/014901s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf | |
| 06/16/2011 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf | |
| 01/28/2010 | SUPPL-37 | 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/2010/012041s036,01401s037ltr.pdf | |
| 01/05/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/2006 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014901s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/014901_S034_Kenalog_40.pdf | |
| 05/22/1996 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1995 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1994 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1991 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S029_Kenalog_40.pdf |
| 02/14/1992 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S028_Kenalog.pdf |
| 11/19/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/13/1984 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1982 | 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)-Control |
Label is not available on this site. |
||
| 04/07/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1978 | SUPPL-10 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S010_Kenalog_40.pdf |
| 07/27/1979 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/014901_S009_Kenalog_40.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/12/2019 | SUPPL-47 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/014901Orig1s047lbl.pdf | |
| 06/22/2018 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s045lbl.pdf | |
| 03/29/2018 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014901s044lbl.pdf | |
| 07/03/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014901s042lbledt.pdf | |
| 07/15/2011 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s039lbl.pdf | |
| 06/16/2011 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014901s038lbl.pdf | |
| 01/28/2010 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf | |
| 11/20/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014901s034lbl.pdf |
KENALOG-40
INJECTABLE;INJECTION; 40MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 014901 | APOTHECON |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 207550 | AMNEAL |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 212400 | EUGIA PHARMA |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 213543 | LONG GROVE PHARMS |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 212567 | MYLAN LABS LTD |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 209852 | TEVA PHARMS USA |
KENALOG-80
There are no Therapeutic Equivalents.