Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008762
Company: PARKE DAVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILANTIN-125 PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription AB Yes Yes
DILANTIN-30 PHENYTOIN 30MG/5ML SUSPENSION;ORAL 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
01/06/1953 ORIG-1 Approval Type 2 - New Active Ingredient 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
07/12/2019 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008762s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008762Orig1s063, 020450Orig1s039ltr.pdf
10/18/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008762s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008762Orig1s062ltr.pdf
10/31/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf
10/31/2017 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020450Orig1s037s038,008762Orig1s060s061,10151Orig1s047s48ltr.pdf
08/15/2017 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008762Orig1s059,010151Orig1s046ltr.pdf
11/30/2016 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf
11/30/2016 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008762Orig1s057,s058,010151Orig1s044,s045ltr.pdf
06/16/2016 SUPPL-55 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf
01/25/2016 SUPPL-54 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
04/30/2015 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/15/2015 SUPPL-52 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-51 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-50 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
09/06/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/08/2013 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

03/06/2013 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008762Orig1s047ltr.pdf
12/14/2011 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf
05/27/2011 SUPPL-42 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s042ltr.pdf
12/14/2011 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf
12/14/2011 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf
12/14/2011 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/008762Orig1s039.pdf
01/17/2011 SUPPL-38 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s038ltr.pdf
04/23/2009 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008762s036ltr.pdf
12/14/2011 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf
03/24/2003 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08762slr031ltr.pdf
02/24/1998 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2001 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf
07/10/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1996 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2001 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf
11/20/2001 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf
11/20/2001 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf
03/23/1990 SUPPL-19 Labeling

Label is not available on this site.

03/23/1990 SUPPL-18 Labeling

Label is not available on this site.

03/23/1990 SUPPL-17 Labeling

Label is not available on this site.

12/08/1980 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/24/1979 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/16/1979 SUPPL-13 Labeling

Label is not available on this site.

11/22/1978 SUPPL-12 Labeling

Label is not available on this site.

02/23/1978 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2019 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008762s063lbl.pdf
10/18/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008762s062lbl.pdf
10/31/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf
10/31/2017 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf
08/15/2017 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s059lbl.pdf
11/30/2016 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf
11/30/2016 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s057s058lbl.pdf
06/16/2016 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf
01/25/2016 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf
04/15/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf
04/03/2014 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf
01/24/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf
03/06/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf
12/14/2011 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
12/14/2011 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
12/14/2011 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
12/14/2011 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
12/14/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
12/14/2011 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf
01/17/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf
01/17/2011 SUPPL-38 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf
04/23/2009 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf

DILANTIN-125

SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN-125 PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription Yes AB 008762 PARKE DAVIS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040521 TARO
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040342 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040610 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040420 WOCKHARDT BIO AG

DILANTIN-30

There are no Therapeutic Equivalents.

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