Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204309
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
06/10/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204309Orig1s000ltr.pdf

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

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