Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020450
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEREBYX | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 08/05/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020450Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2022 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020450s046lbl.pdf | |
| 12/02/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020450Orig1s045Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020450Orig1s045ltr.pdf | |
| 02/16/2021 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020450s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020450Orig1s042ltr.pdf | |
| 01/28/2020 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020450s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020450Orig1s040ltr.pdf | |
| 07/12/2019 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020450s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008762Orig1s063, 020450Orig1s039ltr.pdf | |
| 10/31/2017 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf | |
| 10/31/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf | |
| 03/10/2017 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s036ltr.pdf | |
| 11/04/2016 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s033ltr.pdf | |
| 06/16/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s031lbledt.pdf | |
| 06/01/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s029ltr.pdf | |
| 06/04/2015 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020450s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020450Orig1s028ltr.pdf | |
| 06/09/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s025ltr.pdf | |
| 10/22/2013 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s024ltr.pdf | |
| 01/03/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s023ltr.pdf | |
| 08/30/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s020ltr.pdf | |
| 11/13/2011 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf | |
| 11/13/2011 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf | |
| 11/13/2011 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf | |
| 11/13/2011 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf | |
| 01/02/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-5 | Labeling |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s005TOC.cfm | |
| 08/13/2001 | SUPPL-4 | Labeling |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s004TOC.cfm | |
| 03/01/2017 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s003ltr.pdf | |
| 11/20/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/26/1996 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020450a_s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020450s046lbl.pdf | |
| 12/02/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020450Orig1s045Lbl.pdf | |
| 02/16/2021 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020450s042lbl.pdf | |
| 01/28/2020 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020450s040lbl.pdf | |
| 07/12/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020450s039lbl.pdf | |
| 10/31/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf | |
| 10/31/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s037s038lbl.pdf | |
| 03/10/2017 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450Orig1s036lbl.pdf | |
| 03/01/2017 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020450s003lbl.pdf | |
| 11/04/2016 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s033lbl.pdf | |
| 06/16/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s031lbledt.pdf | |
| 03/03/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s029lbl.pdf | |
| 06/04/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020450s028lbl.pdf | |
| 06/12/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf | |
| 01/03/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf | |
| 10/22/2013 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450Orig1s024lbl.pdf | |
| 03/06/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450s020lbl.pdf | |
| 11/13/2011 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf | |
| 11/13/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf | |
| 11/13/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf | |
| 11/13/2011 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf | |
| 08/13/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf | |
| 08/13/2001 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf |
CEREBYX
INJECTABLE;INJECTION; EQ 50MG PHENYTOIN NA/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEREBYX | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020450 | PARKE DAVIS |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078052 | FRESENIUS KABI USA |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214926 | GLAND PHARMA LTD |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077481 | HIKMA |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077989 | HIKMA |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078765 | HIKMA FARMACEUTICA |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078417 | SUN PHARM |
| FOSPHENYTOIN SODIUM | FOSPHENYTOIN SODIUM | EQ 50MG PHENYTOIN NA/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078137 | WOCKHARDT |