Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084349
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN SODIUM | 30MG EXTENDED | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| DILANTIN | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/27/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/2022 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/084349s088lbl.pdf | |
| 10/22/2021 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf | |
| 08/07/2020 | SUPPL-86 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/084349s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/084349s086ltr.pdf | |
| 12/03/2018 | SUPPL-85 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf | |
| 12/22/2017 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 12/22/2017 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 12/22/2017 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 02/01/2017 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf | |
| 02/01/2017 | SUPPL-79 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-78 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-77 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-75 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2015 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084349Orig1s074ltr.pdf | |
| 07/03/2014 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf | |
| 02/27/2014 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf | |
| 12/26/2013 | SUPPL-71 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/06/2013 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084349Orig1s070ltr.pdf | |
| 11/27/2012 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084349Orig1s067ltr.pdf | |
| 04/08/2011 | SUPPL-64 | REMS-Proposal |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf | |
| 02/27/2014 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf | |
| 05/06/2009 | SUPPL-60 | Labeling, REMS-Proposal |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf | |
| 07/09/2009 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 08/08/2007 | SUPPL-45 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf |
| 08/08/2007 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/09/2003 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1993 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-26 | Bioequivalence |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/07/2022 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/084349s088lbl.pdf | |
| 10/22/2021 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf | |
| 08/07/2020 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/084349s086lbl.pdf | |
| 12/03/2018 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf | |
| 12/22/2017 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 12/22/2017 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 12/22/2017 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf | |
| 02/01/2017 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf | |
| 04/16/2015 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf | |
| 07/03/2014 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf | |
| 02/27/2014 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf | |
| 02/27/2014 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf | |
| 08/06/2013 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf | |
| 11/27/2012 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf | |
| 04/08/2011 | SUPPL-64 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf | |
| 05/06/2009 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf | |
| 05/06/2009 | SUPPL-60 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf |
DILANTIN
CAPSULE;ORAL; 100MG EXTENDED
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | Yes | AB | 084349 | VIATRIS |
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040765 | AMNEAL PHARMS NY |
| EXTENDED PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 040684 | TARO |
| PHENYTOIN SODIUM | PHENYTOIN SODIUM | 100MG EXTENDED | CAPSULE;ORAL | Prescription | No | AB | 204309 | AUROBINDO PHARMA |