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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040684
Company: TARO

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/05/2006 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
01/18/2014 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
01/18/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
12/15/2009 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 Yes AB 084349 VIATRIS
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 040684 TARO
PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 204309 AUROBINDO PHARMA
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