Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200565
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;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
04/17/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2017 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/09/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PHENYTOIN

TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 084427 PFIZER
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 040884 EPIC PHARMA LLC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200691 MYLAN PHARMS INC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200565 TARO

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English