Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208218
Company: PAR PHARM INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription AA 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
04/27/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208218Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2017 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.

VIGABATRIN

FOR SOLUTION;ORAL; 500MG/PACKET
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SABRIL VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription Yes AA 022006 LUNDBECK PHARMS LLC
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 210155 AMNEAL PHARMS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 208218 PAR PHARM INC

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