Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084427
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILANTIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription AB No 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
02/26/1979 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/084427.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2018 SUPPL-42 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf
12/22/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
12/22/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
12/22/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
02/01/2017 SUPPL-37 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf
02/01/2017 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

02/01/2017 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

02/01/2017 SUPPL-34 Labeling-Medication Guide

Label is not available on this site.

02/01/2017 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

04/16/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084427Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084427Orig1s032ltr.pdf
07/01/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427Orig1s031lbl.pdf
02/27/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
12/26/2013 SUPPL-29 Labeling

Label is not available on this site.

08/06/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084427Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084427Orig1s028ltr.pdf
11/27/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084427s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084427Orig1s026ltr.pdf
02/27/2014 SUPPL-25 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
04/08/2011 SUPPL-23 REMS-Proposal Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf
02/27/2014 SUPPL-22 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
05/06/2009 SUPPL-20 REMS-Proposal, Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf
02/27/2014 SUPPL-17 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
06/06/2003 SUPPL-16 Labeling

Label is not available on this site.

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

Label is not available on this site.

06/23/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/11/1995 SUPPL-13 Labeling

Label is not available on this site.

08/05/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/06/1995 SUPPL-11 Labeling

Label is not available on this site.

11/12/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/12/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/02/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/17/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/22/1981 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2018 SUPPL-42 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf
12/03/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf
12/22/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
12/22/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
12/22/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf
02/01/2017 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s037lbl.pdf
04/16/2015 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084427Orig1s032lbl.pdf
07/01/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427Orig1s031lbl.pdf
02/27/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
02/27/2014 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
02/27/2014 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
02/27/2014 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084427s017s022s025s030lbl.pdf
08/06/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084427Orig1s028lbl.pdf
11/27/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084427s026lbl.pdf
04/08/2011 SUPPL-23 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf
05/06/2009 SUPPL-20 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf
05/06/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084427s020lbl.pdf

DILANTIN

TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 084427 PFIZER
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 040884 EPIC PHARMA LLC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200691 MYLAN PHARMS INC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200565 TARO

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