FDA.reportPublic FDA data

Application 075091

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET, EXTENDED RELEASE;ORAL50MG;200MGNoNo
002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET, EXTENDED RELEASE;ORAL25MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0088Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0088Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0088Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0088Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0088Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0094Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0094Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0094Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0094Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0094Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0615-4568Carbidopa and LevodopaCarbidopa and LevodopaNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4569Carbidopa and LevodopaCarbidopa and LevodopaNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-327Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-327Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-923Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-923Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-923Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-978Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-978Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-978Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
67544-672Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-672Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30753ORIG2004-06-24
22416ORIG1999-09-30
18387ORIG1999-09-30