FDA.reportPublic FDA data

Application 071620

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMAZEPAMTEMAZEPAMCAPSULE;ORAL30MGNoNo
002TEMAZEPAMTEMAZEPAMCAPSULE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2076TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2076TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2076TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2076TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2076TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2077TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2077TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2077TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2077TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
0228-2077TemazepamTemazepamActavis Pharma, Inc.ANDACurrent
50090-2356TemazepamTemazepamA-S Medication SolutionsANDACurrent
50090-2356TemazepamTemazepamA-S Medication SolutionsANDACurrent
50090-2391TemazepamTemazepamA-S Medication SolutionsANDACurrent
50436-4628TemazepamTemazepamUnit Dose ServicesANDACurrent
50436-4628TemazepamTemazepamUnit Dose ServicesANDACurrent
50436-4629TemazepamTemazepamUnit Dose ServicesANDACurrent
60429-506TemazepamTemazepamGSMS, IncorporatedANDACurrent
60429-506TemazepamTemazepamGolden State Medical Supply, Inc.ANDACurrent
60429-506TemazepamTemazepamGolden State Medical SupplyANDACurrent
60429-506TemazepamTemazepamGolden State Medical Supply, Inc.ANDACurrent
60429-507TemazepamTemazepamGSMS, IncorporatedANDACurrent
60429-507TemazepamTemazepamGolden State Medical Supply, Inc.ANDACurrent
60429-507TemazepamTemazepamGolden State Medical SupplyANDACurrent
60429-507TemazepamTemazepamGolden State Medical Supply, Inc.ANDACurrent
61919-438TEMAZEPAMTEMAZEPAMDirect RxANDACurrent
61919-438TEMAZEPAMTEMAZEPAMDirect RxANDACurrent
61919-438TEMAZEPAMTEMAZEPAMDirect RxANDACurrent
63629-7713TemazepamTemazepamBryant Ranch PrepackANDACurrent
63629-7715TemazepamTemazepamBryant Ranch PrepackANDACurrent
63629-7715TemazepamTemazepamBryant Ranch PrepackANDACurrent
68071-4083TemazepamTemazepam CIVNuCare Pharmaceuticals,InANDACurrent
68071-4083TemazepamTemazepam CIVNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4083TemazepamTemazepam CIVNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4100TemazepamTemazepam CIVNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4100TemazepamTemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6986TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-6986TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-6986TemazepamTemazepamPreferred PharmaceuticalsANDACurrent
68788-6986TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-6986TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7163TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7163TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7163TemazepamTemazepamPreferred PharmaceuticalsANDACurrent
68788-7163TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7163TemazepamTemazepamPreferred Pharmaceuticals Inc.ANDACurrent
70518-2487TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-2487TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-2487TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-2487TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-2487TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
70518-2926TemazepamTemazepamREMEDYREPACK INC.ANDACurrent
71335-0315TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-0315TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-0315TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-0527TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-0527TemazepamTemazepamBryant Ranch PrepackANDACurrent
71335-0527TemazepamTemazepamBryant Ranch PrepackANDACurrent