FDA.report

Application 071456

Type
ANDA
Sponsor
NOVEL LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TEMAZEPAMTEMAZEPAMCAPSULE;ORAL15MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-8475temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8475temazepamtemazepamLiberty Pharmaceuticals, Inc.ANDACurrent
17856-0148temazepamtemazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0148temazepamtemazepamATLANTIC BIOLOGICALS CORP.ANDACurrent
21695-282temazepamtemazepamRebel Distributors CorpANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-664temazepamtemazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
40032-121TemazepamTemazepamNovel Laboratories, Inc.ANDACurrent
43353-312temazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0186temazepamtemazepamA-S Medication SolutionsANDACurrent
50090-0186temazepamtemazepamA-S Medication SolutionsANDACurrent
50090-0186temazepamtemazepamA-S Medication SolutionsANDACurrent
50090-0186temazepamtemazepamA-S Medication SolutionsANDACurrent
50090-0186temazepamtemazepamA-S Medication SolutionsANDACurrent
52959-535temazepamtemazepamH.J. Harkins Company, Inc.ANDACurrent
55289-196temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-196temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-196temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-196temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-196temazepamtemazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-263TEMAZEPAMTEMAZEPAMDirectRXANDACurrent
63187-132temazepamtemazepamProficient Rx LPANDACurrent
63187-132temazepamtemazepamProficient Rx LPANDACurrent
63629-1054temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1054temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1054temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1055temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1619temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1619temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1619temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1619temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-1619temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8602temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8602temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8603temazepamtemazepamBryant Ranch PrepackANDACurrent
63629-8603temazepamtemazepamBryant Ranch PrepackANDACurrent
63739-877temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-877temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-877temazepamtemazepamMcKesson Corporation dba SKY PackagingANDACurrent
64725-1460temazepamtemazepamTYA PharmaceuticalsANDACurrent
66267-415temazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
67877-146temazepamtemazepamAscend Laboratories, LLCANDACurrent
67877-146temazepamtemazepamAscend Laboratories, LLCANDACurrent
67877-146temazepamtemazepamAscend Laboratories, LLCANDACurrent
68071-2581TemazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2581TemazepamtemazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8139temazepamtemazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-9865temazepamtemazepamPreferred PharmaceuticalsANDACurrent
70518-0647temazepamtemazepamREMEDYREPACK INC.ANDACurrent
70518-0647temazepamtemazepamREMEDYREPACK INC.ANDACurrent
71205-914temazepamtemazepamProficient Rx LPANDACurrent
71205-914temazepamtemazepamProficient Rx LPANDACurrent
71610-086temazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-089temazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0191TemazepamTemazepamAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent