FDA.reportPublic FDA data

Application 071457

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-8474temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8474temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8476temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8476temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8477temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8477temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0904-6436TemazepamTemazepamMajor PharmaceuticalsANDACurrent
0904-6436TemazepamTemazepamMajor PharmaceuticalsANDACurrent
0904-6436TemazepamTemazepamMajor PharmaceuticalsANDACurrent
0904-6436TemazepamTemazepamMajor PharmaceuticalsANDACurrent
21695-283temazepamtemazepamRebel Distributors CorpANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-663temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-821temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
40032-120TemazepamTemazepamNovel Laboratories, Inc.ANDACurrent
40032-122TemazepamTemazepamNovel Laboratories, Inc.ANDACurrent
40032-123TemazepamTemazepamNovel Laboratories, Inc.ANDACurrent
43353-152TemazepamTemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-260temazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0285temazepamtemazepamA-S Medication SolutionsANDACurrent
50436-4630temazepamtemazepamUnit Dose ServicesANDACurrent
52959-459temazepamtemazepamH.J. Harkins Company, Inc.ANDACurrent
53217-205temazepamtemazepamAidarex Pharmaceuticals LLCANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-660temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-264TEMAZEPAMTEMAZEPAMDirectRXANDACurrent
61919-264TEMAZEPAMTEMAZEPAMDirectRXANDACurrent
63187-497temazepamtemazepamProficient Rx LPANDACurrent
63187-497temazepamtemazepamProficient Rx LPANDACurrent
63629-1056temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1057temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1057temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1057temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1057temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1621temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1621temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1621temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1621temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1621temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8601temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8601temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8604temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8604temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8605temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8605temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8606temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8606temazepamtemazepamBryant Ranch PrepackANDACurrent
63739-003temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-003temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-003temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-003temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-003temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-125temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-125temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-125temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
66267-321temazepamtemazepam CIVNuCare Pharmaceuticals,Inc.ANDACurrent
66267-321temazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
66267-321temazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
66267-321temazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
67877-147temazepamtemazepamAscend Laboratories, LLCANDACurrent
67877-147temazepamtemazepamAscend Laboratories, LLCANDACurrent
67877-147temazepamtemazepamAscend Laboratories, LLCANDACurrent
67877-148temazepamtemazepamAscend Laboratories, LLCANDACurrent