Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010151
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILANTIN | PHENYTOIN SODIUM | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/01/1956 | 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 |
|---|---|---|---|---|---|
| 10/31/2017 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf | |
| 10/31/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf | |
| 08/15/2017 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008762Orig1s059,010151Orig1s046ltr.pdf | |
| 11/30/2016 | SUPPL-45 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf |
| 11/30/2016 | SUPPL-44 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf |
| 06/16/2016 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf | |
| 01/25/2016 | SUPPL-41 | 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 | |
| 04/15/2015 | SUPPL-40 | 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-39 | 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-38 | 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 | |
| 03/06/2013 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010151Orig1s037ltr.pdf | |
| 11/13/2011 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010151s036ltr.pdf | |
| 05/30/1997 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-34 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S034_DILANTIN_AP.pdf |
| 11/20/2001 | SUPPL-33 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S033_DILANTIN_AP.pdf |
| 11/20/2001 | SUPPL-32 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S032_DILANTIN_AP.pdf |
| 11/22/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-30 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S030_DILANTIN_AP.pdf |
| 11/20/2001 | SUPPL-29 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S029_DILANTIN_AP.pdf |
| 09/30/1986 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1986 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1986 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/10/1983 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-22 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S022_DILANTIN_AP.pdf |
| 06/02/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/03/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1979 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/30/1978 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/28/1977 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/05/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/31/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf | |
| 10/31/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s047s048lbl.pdf | |
| 08/15/2017 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010151s046lbl.pdf | |
| 06/16/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf | |
| 01/25/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf | |
| 04/15/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf | |
| 04/03/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf | |
| 01/24/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf | |
| 03/06/2013 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf | |
| 11/13/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf |