Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084427
Company: PHARMACIA
Company: PHARMACIA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 02/26/1979 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/084427.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/08/2023 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2021 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2018 | SUPPL-42 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf | |
| 12/22/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 12/22/2017 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 12/22/2017 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 02/01/2017 | SUPPL-37 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf | |
| 02/01/2017 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-34 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/01/2017 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2015 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084427Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084427Orig1s032ltr.pdf | |
| 07/01/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427Orig1s031lbl.pdf | |
| 02/27/2014 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 12/26/2013 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/06/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084427Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084427Orig1s028ltr.pdf | |
| 11/27/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084427s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084427Orig1s026ltr.pdf | |
| 02/27/2014 | SUPPL-25 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 04/08/2011 | SUPPL-23 | REMS-Proposal |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf | |
| 02/27/2014 | SUPPL-22 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 05/06/2009 | SUPPL-20 | Labeling, REMS-Proposal |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf | |
| 02/27/2014 | SUPPL-17 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 06/06/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/05/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/12/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1981 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 12/03/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf | |
| 12/03/2018 | SUPPL-42 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf | |
| 12/22/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 12/22/2017 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 12/22/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf | |
| 02/01/2017 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf | |
| 04/16/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084427Orig1s032lbl.pdf | |
| 07/01/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427Orig1s031lbl.pdf | |
| 02/27/2014 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 02/27/2014 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 02/27/2014 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 02/27/2014 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf | |
| 08/06/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084427Orig1s028lbl.pdf | |
| 11/27/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084427s026lbl.pdf | |
| 04/08/2011 | SUPPL-23 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf | |
| 05/06/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf | |
| 05/06/2009 | SUPPL-20 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf |
DILANTIN
TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 084427 | PHARMACIA |
| PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 040884 | EPIC PHARMA LLC |
| PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200691 | RISING |
| PHENYTOIN | PHENYTOIN | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200565 | TARO |