FDA.reportPublic FDA data

Application 203482

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMAZEPAMTEMAZEPAMCAPSULE;ORAL7.5MGNoNo
002TEMAZEPAMTEMAZEPAMCAPSULE;ORAL15MGNoNo
003TEMAZEPAMTEMAZEPAMCAPSULE;ORAL22.5MGNoNo
004TEMAZEPAMTEMAZEPAMCAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-556TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-556TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-556TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-556TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-557TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-557TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-557TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-557TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-583TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-583TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-583TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-583TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-584TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-584TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-584TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
65162-584TemazepamTemazepamAmneal Pharmaceuticals LLCANDACurrent
68788-6904TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
70518-3227TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-3229TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-3229TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
71335-1901TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-1901TemazepamTemazepamBryant Ranch PrepackANDACurrent