Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078476
Company: AMNEAL

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
03/18/2008 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2019 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
10/21/2019 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
10/21/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
10/21/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
10/15/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
04/15/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
04/15/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
04/15/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
04/15/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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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