Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040573
Company: ACELLA

Products on ANDA 040573

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2006	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
02/16/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/06/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/27/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040573

PHENYTOIN SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040573	ACELLA
PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	084307	WEST-WARD PHARMS INT