FDA.reportPublic FDA data

Application 077657

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORAZEPAMLORAZEPAMTABLET;ORAL0.5MGNoNo
002LORAZEPAMLORAZEPAMTABLET;ORAL1MGNoNo
003LORAZEPAMLORAZEPAMTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2321LorazepamlorazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-2321LorazepamlorazepamMylan Pharmaceuticals IncANDACurrent
0378-2457LorazepamlorazepamMylan Pharmaceuticals IncANDACurrent
0378-2457LorazepamlorazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-2777LorazepamlorazepamMylan Pharmaceuticals IncANDACurrent
0378-2777LorazepamlorazepamMylan Pharmaceuticals Inc.ANDACurrent
0615-7805LorazepamlorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
35356-844LorazepamlorazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3093LorazepamlorazepamA-S Medication SolutionsANDACurrent
50090-3146LorazepamlorazepamA-S Medication SolutionsANDACurrent
51079-386LorazepamlorazepamMylan Institutional Inc.ANDACurrent
51079-387LorazepamlorazepamMylan Institutional Inc.ANDACurrent
51079-417LorazepamlorazepamMylan Institutional Inc.ANDACurrent
53002-7720LorazepamlorazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-7720LorazepamlorazepamRPK Pharmaceuticals, Inc.ANDACurrent
55154-5550LorazepamlorazepamCardinal HealthANDACurrent
55154-5550LorazepamlorazepamCardinal HealthANDACurrent
55154-5590LorazepamlorazepamCardinal HealthANDACurrent
55154-5590LorazepamlorazepamCardinal HealthANDACurrent
55154-5655LorazepamlorazepamCardinal HealthANDACurrent
55154-5655LorazepamlorazepamCardinal HealthANDACurrent
63187-208LorazepamlorazepamProficient Rx LPANDACurrent
63187-208LorazepamlorazepamProficient Rx LPANDACurrent
63187-417LorazepamlorazepamProficient Rx LPANDACurrent
63187-417LorazepamlorazepamProficient Rx LPANDACurrent
63187-868LorazepamlorazepamProficient Rx LPANDACurrent
63187-868LorazepamlorazepamProficient Rx LPANDACurrent
67296-0726LorazepamlorazepamRedPharm Inc.ANDACurrent
67544-870LorazepamlorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-879LorazepamlorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-982LorazepamlorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
70518-0155LorazepamlorazepamREMEDYREPACK INC.ANDACurrent
70518-0156LorazepamlorazepamREMEDYREPACK INC.ANDACurrent