FDA.reportPublic FDA data

Application 075049

Type
ANDA
Sponsor
APNAR PHARMA LP

Application Products#

Product, Drug, Ingredient table
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#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1387Fluoxetine HydrochlorideFluoxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-2822Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
0781-2822Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
0781-2823Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
0781-2823Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
0781-2824Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
0781-2824Fluoxetine HydrochlorideFluoxetine HydrochlorideSandoz IncANDACurrent
43353-637Fluoxetine HydrochlorideFluoxetine HydrochlorideAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
53808-0366Fluoxetine HydrochlorideFluoxetine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0986Fluoxetine HydrochlorideFluoxetine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0988Fluoxetine HydrochlorideFluoxetine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
55289-610FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-610FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-610FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-610FluoxetineFluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
60760-282Fluoxetine HydrochlorideFluoxetine HydrochlorideSt. Marys Medical Park PharmacyANDACurrent
61919-099FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEDIRECT RXANDACurrent
63629-6855Fluoxetine HydrochlorideFluoxetine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6855Fluoxetine HydrochlorideFluoxetine HydrochlorideBryant Ranch PrepackANDACurrent
67544-848Fluoxetine HydrochlorideFluoxetine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
70518-0170Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0170Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0170Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0642Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0642Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0769Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0769Fluoxetine HydrochlorideFluoxetine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-141Fluoxetine HydrochlorideFluoxetine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-141Fluoxetine HydrochlorideFluoxetine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-141Fluoxetine HydrochlorideFluoxetine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-394Fluoxetine HydrochlorideFluoxetine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-394Fluoxetine HydrochlorideFluoxetine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23757ORIG2005-08-01
18383ORIG2004-06-04
8503SUPPL2004-06-04
8502ORIG2004-06-04
22408ORIG2003-08-04
30742SUPPL2003-04-09
30741SUPPL2003-04-09
30740SUPPL2003-04-09
8508SUPPL2003-04-09
8507SUPPL2003-04-09
8506SUPPL2003-04-09
8505SUPPL2003-04-09
8504SUPPL2003-04-09