Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040621
Company: SUN PHARM INDS (IN)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG EXTENDED CAPSULE;ORAL 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
12/11/2006 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/040621_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2014 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/21/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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