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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204309
Company: AUROBINDO PHARMA

Products on ANDA 204309

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204309

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/03/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/03/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/03/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/03/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/03/2023	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204309

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

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