FDA.reportPublic FDA data

Application 076001

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7625FluoxetineFluoxetineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7625FluoxetineFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7625FluoxetineFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7638FluoxetineFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8093FluoxetineFluoxetineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8093FluoxetineFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8093FluoxetineFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-5784FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5784FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5784FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5784FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5785FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5785FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5785FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
0904-5785FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
10544-181FluoxetineFluoxetineBlenheim Pharmacal, Inc.ANDACurrent
10544-582FluoxetineFluoxetineBlenheim Pharmacal, Inc.ANDACurrent
33261-184FluoxetineFluoxetineAidarex Pharmaceuticals LLCANDACurrent
42254-235FluoxetineFluoxetineRebel Distributors CorpANDACurrent
42291-396FluoxetineFluoxetineAvKARE, Inc.ANDACurrent
42291-396FluoxetineFluoxetineAvKARE, Inc.ANDACurrent
42291-396FluoxetineFluoxetineAvKAREANDACurrent
42291-397FluoxetineFluoxetineAvKARE, Inc.ANDACurrent
42291-397FluoxetineFluoxetineAvKARE, Inc.ANDACurrent
42291-397FluoxetineFluoxetineAvKAREANDACurrent
42708-025FluoxetineFluoxetineQPharma IncANDACurrent
42708-025FluoxetineFluoxetineQPharma IncANDACurrent
42708-025FluoxetineFluoxetineQPharma IncANDACurrent
50090-0744FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-2776FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-2776FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-3180FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-3180FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-3332FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50090-3332FluoxetineFluoxetineA-S Medication SolutionsANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-647FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-648FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
51655-101fluoxetine hydrochloridefluoxetine hydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
53002-2305FluoxetineFluoxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-5016FluoxetineFluoxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-5016FluoxetineFluoxetineRPK Pharmaceuticals, Inc.ANDACurrent
53217-155FluoxetineFluoxetineAidarex Pharmaceuticals LLCANDACurrent
55154-1341FluoxetineFluoxetineCardinal HealthANDACurrent
55154-1341FluoxetineFluoxetineCardinal HealthANDACurrent
55154-6890FluoxetineFluoxetineCardinal HealthANDACurrent
55700-089FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-089FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-089FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-177FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-177FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0645FluoxetineFluoxetineClinical Solutions Wholesale, LLCANDACurrent
58118-0645FluoxetineFluoxetineClinical Solutions Wholesale, LLCANDACurrent
58118-0645FluoxetineFluoxetineClinical Solutions Wholesale, LLCANDACurrent
58118-0645FluoxetineFluoxetineClinical Solutions Wholesale, LLCANDACurrent
60760-259FluoxetineFluoxetineSt Mary's Medical Park PharmacyANDACurrent
61919-100FLUOXETINEFLUOXETINEDirect_RxANDACurrent
61919-100FLUOXETINEFLUOXETINEDirect_RxANDACurrent
61919-100FLUOXETINEFLUOXETINEDirect_RxANDACurrent
61919-340FLUOXETINEFLUOXETINEDIRECT RXANDACurrent
63187-233FluoxetineFluoxetineProficient Rx LPANDACurrent
63187-233FluoxetineFluoxetineProficient Rx LPANDACurrent
63187-233FluoxetineFluoxetineProficient Rx LPANDACurrent
63629-6770FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
63629-6770FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
63629-8179FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
63629-8179FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
63629-8179FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
66116-453FluoxetineFluoxetineMedVantx, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23790ORIG2005-08-01