Application 215601

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIGABATRINVIGABATRINTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-367VigabatrinVigabatrinAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76264ORIG 2023-11-03