FDA.reportPublic FDA data

Application 203455

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NADOLOLNADOLOLTABLET;ORAL20MGNoNo
002NADOLOLNADOLOLTABLET;ORAL40MGNoNo
003NADOLOLNADOLOLTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7070NadololNadololMajor PharmaceuticalsANDACurrent
0904-7070NadololNadololMajor PharmaceuticalsANDACurrent
0904-7070NadololNadololMajor PharmaceuticalsANDACurrent
0904-7071NadololNadololMajor PharmaceuticalsANDACurrent
0904-7071NadololNadololMajor PharmaceuticalsANDACurrent
0904-7071NadololNadololMajor PharmaceuticalsANDACurrent
31722-347NadololNadololCamber, Pharmaceuticals IncANDACurrent
31722-348NadololNadololCamber, Pharmaceuticals IncANDACurrent
31722-349NadololNadololCamber, Pharmaceuticals IncANDACurrent
60687-302NadololNadololAmerican Health PackagingANDACurrent
60687-302NadololNadololAmerican Health PackagingANDACurrent
60687-302NadololNadololAmerican Health PackagingANDACurrent
60687-313NadololNadololAmerican Health PackagingANDACurrent
60687-313NadololNadololAmerican Health PackagingANDACurrent
60687-313NadololNadololAmerican Health PackagingANDACurrent
60687-324NadololNadololAmerican Health PackagingANDACurrent
67787-347NadololNadololInvaGen Pharmaceuticals Inc.ANDACurrent
67787-348NadololNadololInvaGen Pharmaceuticals Inc.ANDACurrent
67787-349NadololNadololInvaGen Pharmaceuticals Inc.ANDACurrent
68001-317NadololNadololBluePoint LaboratoriesANDACurrent
68001-318NadololNadololBluePoint LaboratoriesANDACurrent
68001-319NadololNadololBluePoint LaboratoriesANDACurrent
69097-867NadololNadololCipla USA Inc.ANDACurrent
69097-867NadololNadololCipla USA Inc.ANDACurrent
69097-868NadololNadololCipla USA Inc.ANDACurrent
69097-868NadololNadololCipla USA Inc.ANDACurrent
69097-869NadololNadololCipla USA Inc.ANDACurrent
69097-869NadololNadololCipla USA Inc.ANDACurrent
70518-1755NadololNadololREMEDYREPACK INC.ANDACurrent
70518-1755NadololNadololREMEDYREPACK INC.ANDACurrent
76282-347NadololNadololExelan Pharmaceuticals Inc.ANDACurrent
76282-348NadololNadololExelan Pharmaceuticals Inc.ANDACurrent
76282-349NadololNadololExelan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10217ORIG2015-12-22