U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209822
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription AB 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
01/14/2019 ORIG-1 Approval STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209822Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209822Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2022 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

10/27/2022 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/02/2020 SUPPL-8 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/26/2021 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/17/2020 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/26/2021 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

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

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SABRIL VIGABATRIN 500MG TABLET;ORAL Prescription Yes AB 020427 LUNDBECK PHARMS LLC
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 210042 AMNEAL PHARMS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215601 AUROBINDO PHARMA LTD
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215109 DEXCEL
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 211539 DR REDDYS
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 213104 HIKMA
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 209822 TEVA PHARMS USA
VIGABATRIN VIGABATRIN 500MG TABLET;ORAL Prescription No AB 215707 ZYDUS
Back to Top