U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210196
Company: AUCTA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGADRONE 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
06/21/2018 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2026 SUPPL-22 REMS - MODIFIED - D-N-A

Label is not available on this site.
09/12/2024 SUPPL-20 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/12/2022 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/08/2022 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
10/02/2020 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/08/2022 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
04/17/2020 SUPPL-5 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/08/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/12/2019 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/08/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
05/30/2019 SUPPL-1 REMS - MODIFIED - D-N-A, REMS-Proposal

Label is not available on this site.

VIGADRONE

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 213375 ALKEM LABS LTD
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 210155 AMNEAL PHARMS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 213519 ANNORA PHARMA
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 213899 AUROBINDO PHARMA LTD
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 211481 DR REDDYS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 211592 INVAGEN PHARMS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 215363 MSN
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 208218 PH HEALTH
VIGADRONE VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 210196 AUCTA
VIGPODER VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 214961 PYROS PHARMS
Back to Top