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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040684
Company: TARO

Products on ANDA 040684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2006	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
07/16/2024	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/16/2024	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/16/2024	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/16/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/16/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2024	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/18/2014	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/18/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040684

EXTENDED 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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