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Drugs@FDA: FDA-Approved Drugs

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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
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
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