Application 211790

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIGABATRINVIGABATRINFOR SOLUTION;ORAL500MG/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-521VigabatrinVigabatrinLupin Pharmaceuticals, Inc.ANDACurrent
68180-521VigabatrinVigabatrinLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76263ORIG 2023-11-03