FDA.reportPublic FDA data

Application 201781

Type
ANDA
Sponsor
PRINSTON INC

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
43547-611TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-611TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-612TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-612TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-613TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-613TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-614TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent
43547-614TemazepamtemazepamSolco Healthcare U.S., LLCANDACurrent