Application 078619

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8183FluoxetineFluoxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-065FluoxetineFluoxetine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-180FluoxetineFluoxetine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-583FluoxetineFluoxetine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
16714-720FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-720FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-720FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-720FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-720FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-721FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-721FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-721FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-721FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-721FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-722FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-722FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-722FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-722FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
16714-722FluoxetineFluoxetine HydrochlorideNorthStar Rx LLCANDACurrent
21695-052FluoxetineFluoxetine HydrochlorideRebel Distributors CorpANDACurrent
21695-053FluoxetineFluoxetine HydrochlorideRebel Distributors CorpANDACurrent
33261-045FluoxetineFluoxetine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
35356-728FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-728FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-728FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-728FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-570FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-712FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-993FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-368FluoxetineFluoxetine HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-0745FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0745FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0745FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0745FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0749FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0749FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2589FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2793FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6064FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6065FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6066FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6081FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50268-333FluoxetineFluoxetine HydrochlorideAvPAKANDACurrent
50268-334FluoxetineFluoxetine HydrochlorideAvPAKANDACurrent
50268-335FluoxetineFluoxetine HydrochlorideAvPAKANDACurrent
50268-335FluoxetineFluoxetine HydrochlorideAvPAKANDACurrent
50436-0924FluoxetineFluoxetine HydrochlorideUnit Dose ServicesANDACurrent
50436-1930FluoxetineFluoxetine HydrochlorideUnit Dose ServicesANDACurrent
51138-093FluoxetineFluoxetine HydrochlorideMed-Health Pharma, LLCANDACurrent
51138-094FluoxetineFluoxetine HydrochlorideMed-Health Pharma, LLCANDACurrent
51138-095FluoxetineFluoxetine HydrochlorideMed-Health Pharma, LLCANDACurrent
51655-100fluoxetine hydrochloridefluoxetine hydrochlorideNorthwind PharmaceuticalsANDACurrent

Documents

DocumentSubmission typeDate
23913ORIG2008-02-28