Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078476
Company: AMNEAL

Products on ANDA 078476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078476

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2008	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
08/24/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
02/17/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/21/2019	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/21/2019	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/21/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/21/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/15/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/15/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.