FDA.reportPublic FDA data

Application 090547

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VORICONAZOLEVORICONAZOLETABLET;ORAL50MGNoNo
002VORICONAZOLEVORICONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1626VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-1640VoriconazolevoriconazoleMylan Pharmaceuticals Inc.ANDACurrent
51079-164VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent
51079-164VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent
51079-164VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent
51079-165VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent
51079-165VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent
51079-165VoriconazolevoriconazoleMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9275ORIG2010-04-28