FDA.reportPublic FDA data

Application 078115

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
003CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-215CarbamazepineCarbamazepineGolden State Medical Supply Inc.ANDACurrent
51672-4123CarbamazepineCarbamazepineTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4124CarbamazepineCarbamazepineTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4125CarbamazepineCarbamazepineTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
53808-1068CarbamazepineCarbamazepineState of Florida DOH Central PharmacyANDACurrent
60687-311CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
60687-311CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
60687-335CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
60687-335CarbamazepineCarbamazepineAmerican Health PackagingANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-0181CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1545CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1769CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1769CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1769CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent
70518-1769CarbamazepineCarbamazepineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44538ORIG2013-01-22
43134ORIG2012-01-27
23893ORIG2009-04-14
9120ORIG2009-04-03