FDA.reportPublic FDA data

Application 076077

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA,ANDACurrent
0172-5410FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA,ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5411FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA,ANDACurrent
0172-5412FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5413FluconazoleFluconazoleTeva Pharmaceuticals USA,ANDACurrent
10544-178FluconazoleFluconazoleBlenheim Pharmacal, Inc.ANDACurrent
33261-229FluconazoleFluconazoleAidarex Pharmaceuticals LLCANDACurrent
42852-003FluconazoleFluconazoleApothecary Shop Wholesale Inc.ANDACurrent
61919-282FLUCONAZOLEFLUCONAZOLEDIRECT RXANDACurrent
61919-419FLUCONAZOLEFLUCONAZOLEDIRECT RXANDACurrent
61919-419FLUCONAZOLEFLUCONAZOLEDIRECT RXANDACurrent
63187-613FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-613FluconazoleFluconazoleProficient Rx LPANDACurrent
63629-8749FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
63629-8749FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
66116-481FluconazoleFluconazoleMedVantx, Inc.ANDACurrent
66116-510FluconazoleFluconazoleMedVantx, Inc.ANDACurrent
66336-570FluconazoleFluconazoleDispensing Solutions, Inc.ANDACurrent
68788-9926FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9927FluconazoleFluconazolePreferred Pharmaceuticals, Inc.ANDACurrent
71205-573FluconazoleFluconazoleProficient Rx LPANDACurrent
71335-1511FluconazoleFluconazoleBryant Ranch PrepackANDACurrent
71335-1511FluconazoleFluconazoleBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31071ORIG2004-07-30