Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010151
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
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
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

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