Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084349
Company: PARKE-DAVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILANTIN PHENYTOIN SODIUM 30MG EXTENDED CAPSULE;ORAL Prescription None No Yes
DILANTIN PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;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
08/27/1976 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2018 SUPPL-85 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf
12/22/2017 SUPPL-84 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017 SUPPL-82 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017 SUPPL-81 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
02/01/2017 SUPPL-80 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf
02/01/2017 SUPPL-79 Labeling-Package Insert

Label is not available on this site.

02/01/2017 SUPPL-78 Labeling-Package Insert

Label is not available on this site.

02/01/2017 SUPPL-77 Labeling-Medication Guide

Label is not available on this site.

02/01/2017 SUPPL-75 Labeling-Package Insert

Label is not available on this site.

04/16/2015 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084349Orig1s074ltr.pdf
07/03/2014 SUPPL-73 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf
02/27/2014 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf
12/26/2013 SUPPL-71 Labeling-Package Insert

Label is not available on this site.

08/06/2013 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084349Orig1s070ltr.pdf
11/27/2012 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084349Orig1s067ltr.pdf
04/08/2011 SUPPL-64 REMS-Proposal Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf
02/27/2014 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf
05/06/2009 SUPPL-60 Labeling, REMS-Proposal Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf
07/09/2009 SUPPL-56 Labeling

Label is not available on this site.

08/08/2007 SUPPL-45 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf
08/08/2007 SUPPL-41 Labeling

Label is not available on this site.

12/09/2003 SUPPL-40 Labeling

Label is not available on this site.

03/25/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/19/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/03/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/11/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/12/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/15/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/22/1990 SUPPL-26 Bioequivalence

Label is not available on this site.

08/25/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/18/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/02/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-5 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-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf
12/22/2017 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
02/01/2017 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf
04/16/2015 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf
07/03/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf
02/27/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf
02/27/2014 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf
08/06/2013 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf
11/27/2012 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf
04/08/2011 SUPPL-64 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf
05/06/2009 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf
05/06/2009 SUPPL-60 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf

DILANTIN

CAPSULE;ORAL; 100MG EXTENDED
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 084349 PARKE-DAVIS
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 040765 AMNEAL PHARMS NY
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 211633 LUPIN LTD
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 040298 MYLAN
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 040684 TARO
PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 204309 AUROBINDO PHARMA LTD

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