FDA.reportPublic FDA data

Application 210155

Type
ANDA
Sponsor
AMNEAL PHARMS

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
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals LLCANDACurrent
69238-1425VigabatrinVigabatrinAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76249ORIG 2023-11-03
52985ORIG2018-03-15