Application 076697

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL200MGNoNo
003CARBAMAZEPINECARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29033-004CarbamazepinecarbamazepineNostrum Laboratories, Inc.ANDACurrent
29033-004CarbamazepineCarbamazepineNostrum Laboratories, Inc.ANDACurrent
29033-019CarbamazepinecarbamazepineNostrum Laboratories, Inc.ANDACurrent
29033-020CarbamazepinecarbamazepineNostrum Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22579ORIG2013-10-23
8950ORIG2011-05-24