An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077481
Company: HIKMA

Products on ANDA 077481

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 077481

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/2007/077481s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077481ltr.pdf

Labels for ANDA 077481

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/2007/077481s000lbl.pdf

Therapeutic Equivalents for ANDA 077481

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	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

Top