Application 209822

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3851VigabatrinVigabatrinActavis Pharma, Inc.ANDACurrent
0591-3851VigabatrinVigabatrinActavis Pharma, Inc.ANDACurrent
0591-3851VigabatrinVigabatrinActavis Pharma, Inc.ANDACurrent
0591-3851VigabatrinVigabatrinActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76528ORIG 2023-11-08
65833ORIG2021-01-06
57720ORIG2019-02-21