Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040731
Company: SUN PHARM INDS

Products on ANDA 040731

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE;ORAL	Prescription	AB	No	No
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040731

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2008	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
03/28/2023	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/28/2023	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/21/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040731

EXTENDED PHENYTOIN SODIUM

CAPSULE;ORAL; 200MG EXTENDED
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE;ORAL	Prescription	No	AB	040731	SUN PHARM INDS
PHENYTEK	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE;ORAL	Prescription	No	AB	040298	MYLAN

CAPSULE;ORAL; 300MG EXTENDED
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE;ORAL	Prescription	No	AB	040731	SUN PHARM INDS
PHENYTEK	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE;ORAL	Prescription	No	AB	040298	MYLAN