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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078137
Company: WOCKHARDT BIO AG

Products on ANDA 078137

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 078137

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/2007/078137s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078137s000ltr.pdf

Labels for ANDA 078137

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/2007/078137s0000lbl.pdf

Therapeutic Equivalents for ANDA 078137

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
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 BIO AG

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