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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040765
Company: AMNEAL PHARMS NY
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
11/12/2008 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
01/03/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/03/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-4 Labeling

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 040298 MYLAN
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 040684 TARO
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 213834 UNICHEM
PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL Prescription No AB 204309 AUROBINDO PHARMA
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