Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078126
Company: APOTEX INC

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 Discontinued None 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/2007/078126s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
10/03/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
10/31/2017 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
10/31/2017 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
06/24/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
06/24/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/24/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
06/24/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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/2007/078126s000lbl.pdf

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