Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077481
Company: WEST-WARD PHARMS INT
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
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
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

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 078476 AMNEAL
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 078765 HIKMA FARMACEUTICA
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078736 MYLAN LABS LTD
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 077481 WEST-WARD PHARMS INT
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 077989 WEST-WARD PHARMS INT
FOSPHENYTOIN SODIUM FOSPHENYTOIN SODIUM EQ 50MG PHENYTOIN NA/ML INJECTABLE;INJECTION Prescription No AP 078137 WOCKHARDT

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