Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200691
Company: RISING

Products on ANDA 200691

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200691

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2012	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
09/27/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/27/2024	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/27/2024	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/27/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/06/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/06/2017	SUPPL-2	Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 200691

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	Yes	AB	084427	PHARMACIA
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	040884	EPIC PHARMA LLC
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200691	RISING
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200565	TARO