CEREBYX از شرکت PARKE DAVIS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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CEREBYX از شرکت PARKE DAVIS

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
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
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 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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