Application 208218

Type
ANDA
Sponsor
PAR PHARM INC

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
49884-358VIGABATRINvigabatrinPar Pharmaceutical, Inc.ANDACurrent
49884-358VIGABATRINvigabatrinPar Pharmaceutical, Inc.ANDACurrent
49884-358VIGABATRINvigabatrinPar Pharmaceutical, Inc.ANDACurrent
49884-358VIGABATRINvigabatrinPar Pharmaceutical, Inc.ANDACurrent
49884-358VIGABATRINvigabatrinPar Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76248ORIG 2023-11-03
48187ORIG2017-05-02