Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040298
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription AB No No
PHENYTEK PHENYTOIN SODIUM 200MG EXTENDED CAPSULE;ORAL Prescription AB No No
PHENYTEK PHENYTOIN SODIUM 300MG 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
12/28/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40298ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040298_phenytoin-sodium_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2016 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

01/08/2014 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

01/08/2014 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/08/2014 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.

01/08/2014 SUPPL-25 Labeling

Label is not available on this site.

04/18/2003 SUPPL-17 Labeling

Label is not available on this site.

03/20/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2002 SUPPL-13 Labeling

Label is not available on this site.

03/20/2002 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/20/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2001 SUPPL-6 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
12/06/2001 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
12/06/2001 SUPPL-4 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40298s4ltr.pdf
01/17/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/2001 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/10/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/28/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf

EXTENDED PHENYTOIN SODIUM

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

PHENYTEK

CAPSULE;ORAL; 200MG EXTENDED
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 200MG EXTENDED CAPSULE;ORAL Prescription No AB 040731 SUN PHARM INDS
PHENYTEK PHENYTOIN SODIUM 200MG EXTENDED CAPSULE;ORAL Prescription No AB 040298 MYLAN

CAPSULE;ORAL; 300MG EXTENDED
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 300MG EXTENDED CAPSULE;ORAL Prescription No AB 040731 SUN PHARM INDS
PHENYTEK PHENYTOIN SODIUM 300MG EXTENDED CAPSULE;ORAL Prescription No AB 040298 MYLAN

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