FDA.report

Application 077253

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-610FluconazoleFluconazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-855FluconazoleFluconazoleBlenheim Pharmacal, Inc.ANDACurrent
21695-131FluconazoleFluconazoleRebel Distributors CorpANDACurrent
21695-193FluconazoleFluconazoleRebel Distributors CorpANDACurrent
21695-560FluconazoleFluconazoleRebel Distributors CorpANDACurrent
33261-487FluconazoleFluconazoleAidarex Pharmaceuticals LLCANDACurrent
43063-326FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-326FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-326FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-326FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-326FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-520FluconazoleFluconazoleLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0869FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-0869FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-0869FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-0869FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50090-5764FluconazoleFluconazoleA-S Medication SolutionsANDACurrent
50436-0103FluconazoleFluconazoleUnit Dose ServicesANDACurrent
53002-4198FluconazoleFluconazoleRPK Pharmaceuticals, Inc.ANDACurrent
55045-3453FluconazoleFluconazoleDispensing Solutions, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-824FluconazoleFluconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-945FluconazoleFluconazoleQuality Care Products, LLCANDACurrent
60760-803FluconazoleFluconazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-803FluconazoleFluconazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-804FluconazoleFluconazoleSt Marys Medical Park PharmacyANDACurrent
61919-333FluconazoleFluconazoleDirect RXANDACurrent
61919-333FluconazoleFluconazoleDirect RXANDACurrent
63187-096FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-096FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-096FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-878FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-878FluconazoleFluconazoleProficient Rx LPANDACurrent
63187-878FluconazoleFluconazoleProficient Rx LPANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-251FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-252FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-253FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68001-254FluconazoleFluconazoleBluePoint LaboratoriesANDACurrent
68071-2114FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2347FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2436FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2557FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2557FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2805FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2906FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4002FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4002FluconazoleFluconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68258-3036FluconazoleFluconazoleDispensing Solutions Inc.ANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-101FluconazoleFluconazoleGlenmark Pharmaceuticals Inc., USAANDACurrent