Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008762
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILANTIN-125 | PHENYTOIN | 125MG/5ML | SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| DILANTIN-30 | PHENYTOIN | 30MG/5ML | SUSPENSION;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/1953 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 03/03/2022 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008762Orig1s066ltr.pdf | |
| 02/16/2021 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008762s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008762Orig1s065ltr.pdf | |
| 07/12/2019 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008762s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008762Orig1s063, 020450Orig1s039ltr.pdf | |
| 10/18/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008762s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008762Orig1s062ltr.pdf | |
| 10/31/2017 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf | |
| 10/31/2017 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf | |
| 08/15/2017 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008762Orig1s059,010151Orig1s046ltr.pdf | |
| 11/30/2016 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf | |
| 11/30/2016 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf | |
| 06/16/2016 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf | |
| 01/25/2016 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/08762Orig1s054,10151Orig1s041ltr.pdf | |
| 04/30/2015 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008762Orig1s052,10151Orig1s040ltr.pdf | |
| 04/03/2014 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151Orig1s039ltr.pdf | |
| 01/24/2014 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s050,010151Orig1s038ltr.pdf | |
| 09/06/2013 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2013 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008762Orig1s047ltr.pdf | |
| 12/14/2011 | SUPPL-43 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf | |
| 05/27/2011 | SUPPL-42 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s042ltr.pdf |
| 12/14/2011 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf | |
| 12/14/2011 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf | |
| 12/14/2011 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/008762Orig1s039.pdf | |
| 01/17/2011 | SUPPL-38 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s038ltr.pdf | |
| 04/23/2009 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008762s036ltr.pdf | |
| 12/14/2011 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf | |
| 03/24/2003 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08762slr031ltr.pdf |
| 02/24/1998 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1997 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf |
| 07/10/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf |
| 11/20/2001 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf |
| 11/20/2001 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf |
| 03/23/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/08/1980 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/16/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/23/1978 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1975 | SUPPL-7 | 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 |
|---|---|---|---|---|---|
| 03/03/2022 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf | |
| 02/16/2021 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008762s065lbl.pdf | |
| 07/12/2019 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008762s063lbl.pdf | |
| 10/18/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008762s062lbl.pdf | |
| 10/31/2017 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf | |
| 10/31/2017 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf | |
| 08/15/2017 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s059lbl.pdf | |
| 11/30/2016 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf | |
| 11/30/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf | |
| 06/16/2016 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf | |
| 01/25/2016 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf | |
| 04/15/2015 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf | |
| 04/03/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf | |
| 01/24/2014 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf | |
| 03/06/2013 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf | |
| 12/14/2011 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 12/14/2011 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 12/14/2011 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 12/14/2011 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 12/14/2011 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 12/14/2011 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf | |
| 01/17/2011 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf | |
| 01/17/2011 | SUPPL-38 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf | |
| 04/23/2009 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf |
DILANTIN-125
SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILANTIN-125 | PHENYTOIN | 125MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 008762 | VIATRIS |
| PHENYTOIN | PHENYTOIN | 125MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 040521 | TARO |
DILANTIN-30
There are no Therapeutic Equivalents.