FDA.reportPublic FDA data

Application 075687

Type
ANDA
Sponsor
TARO PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET, CHEWABLE;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINETABLET, CHEWABLE;ORAL200MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0947CarbamazepineCarbamazepinePharamaceutical Associates, Inc.ANDACurrent
0121-1894CarbamazepineCarbamazepinePharamaceutical Associates, Inc.ANDACurrent
0615-8125CarbamazepineCarbamazepineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8125CarbamazepineCarbamazepineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
51672-4041CarbamazepineCarbamazepineTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
60429-934CarbamazepinecarbamazepineGolden State Medical Supply, Inc.ANDACurrent
60429-934CarbamazepineCarbamazepineGolden State Medical Supply, Inc.ANDACurrent
68788-9812CarbamazepineCarbamazepinePreferred Pharmaceuticals, IncANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1433CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-2426CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-2426CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-2426CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-2426CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24153ORIG2008-02-01
8765ORIG2000-10-24