FDA.reportPublic FDA data

Application 073524

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPITOLCARBAMAZEPINETABLET, CHEWABLE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA,ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0778CarbamazepineCarbamazepineTeva Pharmaceuticals USA, Inc.ANDACurrent
51079-870CarbamazepineCarbamazepineMylan Institutional Inc.ANDACurrent
51079-870CarbamazepineCarbamazepineMylan Institutional Inc.ANDACurrent
63629-8743CarbamazepineCarbamazepineBryant Ranch PrepackANDACurrent
63629-8743CarbamazepineCarbamazepineBryant Ranch PrepackANDACurrent
63629-9292CarbamazepineCarbamazepineBryant Ranch PrepackANDACurrent