Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040521
Company: TARO

Products on ANDA 040521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/2004	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
09/19/2023	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2023	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2023	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/19/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/20/2015	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/16/2014	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/16/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/16/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040521

PHENYTOIN

SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILANTIN-125	PHENYTOIN	125MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	008762	VIATRIS
PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	040521	TARO