Drugs@FDA: FDA Approved Drug Products

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
09/12/2019 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/30/2019 SUPPL-1 REMS-Proposal, REMS - MODIFIED - D-N-A

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 210155 AMNEAL PHARMS
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 211481 DR REDDYS LABS LTD
VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION;ORAL Prescription No AA 208218 PAR PHARM INC
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English