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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078052
Company: FRESENIUS KABI USA

Products on ANDA 078052

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	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078052

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/2007/078052s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078052s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/16/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/30/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/30/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/30/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/30/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/22/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 078052

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/2007/078052s000lbl.pdf

Therapeutic Equivalents for ANDA 078052

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION; EQ 50MG PHENYTOIN NA/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEREBYX	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020450	PARKE DAVIS
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	078052	FRESENIUS KABI USA
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	214926	GLAND PHARMA LTD
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	077481	HIKMA
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	077989	HIKMA
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	078765	HIKMA FARMACEUTICA
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	078417	SUN PHARM
FOSPHENYTOIN SODIUM	FOSPHENYTOIN SODIUM	EQ 50MG PHENYTOIN NA/ML	INJECTABLE;INJECTION	Prescription	No	AP	078137	WOCKHARDT

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