Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020450
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
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
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 078476 AMNEAL
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 078765 HIKMA FARMACEUTICA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078736 MYLAN LABS LTD
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 077481 WEST-WARD PHARMS INT
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 077989 WEST-WARD PHARMS INT
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078137 WOCKHARDT

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