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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078126
Company: APOTEX INC

Products on ANDA 078126

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 078126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2007	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2022	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/01/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/01/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/01/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/31/2017	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/31/2017	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/24/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/24/2016	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/24/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/24/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 078126

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf

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