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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208218
Company: ENDO OPERATIONS

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
09/12/2024 SUPPL-15 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/12/2022 SUPPL-13 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/11/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
10/02/2020 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/11/2023 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
04/17/2020 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.
03/12/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
09/12/2019 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.
03/12/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
05/30/2019 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/23/2017 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.
03/12/2020 SUPPL-1 Labeling

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 208218 ENDO OPERATIONS
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 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
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