Application 214425

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-521VigabatrinVigabatrinAccord Healthcare Inc.ANDACurrent
16729-521VigabatrinVigabatrinAccord Healthcare Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76254ORIG 2023-11-03