Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215109
Company: DEXCEL

• REMS

Products on ANDA 215109

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIGABATRIN	VIGABATRIN	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2021	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
10/12/2022	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 215109

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	215519	PROPEL PHARMA
VIGABATRIN	VIGABATRIN	500MG	TABLET;ORAL	Prescription	No	AB	209822	TEVA PHARMS USA
VIGABATRIN	VIGABATRIN	500MG	TABLET;ORAL	Prescription	No	AB	214749	UPSHER SMITH LABS
VIGABATRIN	VIGABATRIN	500MG	TABLET;ORAL	Prescription	No	AB	215707	ZYDUS LIFESCIENCES