Drugs@FDA: FDA Approved Drug Products

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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)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209822Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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 209822 TEVA PHARMS USA

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