FDA.reportPublic FDA data

Application 204597

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
31722-903FLUOXETINEFLUOXETINECamber Pharmaceuticals, Inc.ANDACurrent
31722-904FLUOXETINEFLUOXETINECamber Pharmaceuticals, Inc.ANDACurrent
31722-905FLUOXETINEFLUOXETINECamber Pharmaceuticals, Inc.ANDACurrent
42543-725FluoxetineFluoxetine HydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-726FluoxetineFluoxetine HydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
42543-727FluoxetineFluoxetine HydrochlorideVensun Pharmaceuticals, Inc.ANDACurrent
45865-359FluoxetineFluoxetine HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-2568FLUOXETINEFLUOXETINEA-S Medication SolutionsANDACurrent
50090-5678FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5678FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6193FluoxetineFluoxetine HydrochlorideA-S Medication SolutionsANDACurrent
50228-113FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-113FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-113FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-113FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-113FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-114FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-114FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-114FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-114FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-114FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-115FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-115FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-115FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-115FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-115FluoxetineFluoxetine HydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50436-0726FluoxetineFluoxetine HydrochlorideUnit Dose ServicesANDACurrent
51655-274FluoxetineFluoxetine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-274FluoxetineFluoxetine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-314FluoxetineFluoxetine HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-314FluoxetineFluoxetine HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-1671FluoxetineFluoxetine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1671FluoxetineFluoxetine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-593FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-609FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-609FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-654FluoxetineFluoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-866FluoxetineFluoxetine HydrochlorideQuality Care Products, LLCANDACurrent
55700-866FluoxetineFluoxetine HydrochlorideQuality Care Products, LLCANDACurrent
60760-311FluoxetineFluoxetine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-745FLUOXETINEFLUOXETINEDirect_RxANDACurrent
63187-361FluoxetineFluoxetine HydrochlorideProficient Rx LPANDACurrent
63187-361FluoxetineFluoxetine HydrochlorideProficient Rx LPANDACurrent
66267-587FLUOXETINEFLUOXETINENuCarePharmaceuticals, Inc.ANDACurrent
66267-587FLUOXETINEFLUOXETINENuCarePharmaceuticals, Inc.ANDACurrent
67046-214FLUOXETINEFLUOXETINEContract Pharmacy Services-PAANDACurrent
67296-1568FluoxetineFluoxetine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1568FluoxetineFluoxetine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1568FluoxetineFluoxetine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-2275FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2275FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2375FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3110FLUOXETINEFLUOXETINENuCare Pharmaceuticals, Inc.ANDACurrent
68071-3130FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4314FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4314FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4653FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5240FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5240FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5240FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5276FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5276FluoxetineFluoxetine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6790FLUOXETINEFLUOXETINEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6790FLUOXETINEFLUOXETINEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6794FLUOXETINEFLUOXETINEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6794FLUOXETINEFLUOXETINEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7409FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7409FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7741FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7817FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7817FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7817FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7909FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7909FluoxetineFluoxetine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69367-235FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
69367-235FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
69367-235FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
69367-235FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
69367-236FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
69367-236FluoxetineFluoxetine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent