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): 210155
Company: AMNEAL PHARMS

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
03/13/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210155Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2022 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.
11/08/2022 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

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

Label is not available on this site.
04/17/2020 SUPPL-8 REMS - MODIFIED - D-N-A

Label is not available on this site.
11/08/2022 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/08/2022 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/12/2019 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/30/2019 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 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 214992 DEXCEL
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 PAR PHARM INC
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 213390 PROPEL PHARMA
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 209824 TEVA PHARMS USA
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