FDA.reportPublic FDA data

Application 070920

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3110TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-3110TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-3120TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-3120TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-4010TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-4010TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-5050TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-5050TemazepamtemazepamMylan Pharmaceuticals Inc.ANDACurrent
33261-101TemazepamtemazepamAidarex Pharmaceuticals LLCANDACurrent
33261-102TemazepamtemazepamAidarex Pharmaceuticals LLCANDACurrent
43353-711TemazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-346TemazepamtemazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-3801TemazepamtemazepamA-S Medication SolutionsANDACurrent
50090-3801TemazepamtemazepamA-S Medication SolutionsANDACurrent
50090-4055TemazepamtemazepamA-S Medication SolutionsANDACurrent
51079-418TemazepamtemazepamMylan Institutional Inc.ANDACurrent
51079-418TemazepamtemazepamMylan Institutional Inc.ANDACurrent
51079-419TemazepamtemazepamMylan Institutional Inc.ANDACurrent
51079-419TemazepamtemazepamMylan Institutional Inc.ANDACurrent
55154-5591TemazepamtemazepamCardinal HealthANDACurrent
55154-5591TemazepamtemazepamCardinal HealthANDACurrent
55154-5591TemazepamtemazepamCardinal HealthANDACurrent
63187-324TemazepamtemazepamProficient Rx LPANDACurrent
63187-324TemazepamtemazepamProficient Rx LPANDACurrent
67544-127TemazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-217TemazepamtemazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
70518-1754TemazepamtemazepamREMEDYREPACK INC.ANDACurrent
70518-1754TemazepamtemazepamREMEDYREPACK INC.ANDACurrent
70518-1944TemazepamtemazepamREMEDYREPACK INC.ANDACurrent
70518-1944TemazepamtemazepamREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42822SUPPL2012-09-12
42821SUPPL2012-09-12
22323SUPPL2012-09-12
22322SUPPL2012-09-12