FDA.reportPublic FDA data

Application 075584

Type
ANDA
Sponsor
APNAR PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL75MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-5535Bupropion HydrochlorideBupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5554Bupropion HydrochlorideBupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1053Bupropion HydrochlorideBupropion HydrochlorideSandoz IncANDACurrent
0781-1064Bupropion HydrochlorideBupropion HydrochlorideSandoz IncANDACurrent
21695-017Bupropion HydrochlorideBupropion HydrochlorideRebel Distributors Corp.ANDACurrent
21695-018Bupropion HydrochlorideBupropion HydrochlorideRebel Distributors Corp.ANDACurrent
24689-119BupropionHydrochlorideTabletsBupropion Hydrochloride TabletsApnar Pharma LPANDACurrent
24689-119BupropionHydrochlorideTabletsBupropion Hydrochloride TabletsApnar Pharma LPANDACurrent
24689-119Bupropion HydrochlorideBupropion HydrochlorideApnar Pharma LPANDACurrent
24689-119Bupropion HydrochlorideBupropion HydrochlorideApnar Pharma LPANDACurrent
24689-120Bupropion HydrochlorideBupropion HydrochlorideApnar Pharma LPANDACurrent
24689-120Bupropion HydrochlorideBupropion HydrochlorideApnar Pharma LPANDACurrent
24689-120BupropionHydrochlorideTabletsBupropion Hydrochloride tabletsApnar Pharma LPANDACurrent
24689-120BupropionHydrochlorideTabletsBupropion Hydrochloride tabletsApnar Pharma LPANDACurrent
33261-012Bupropion HydrochlorideBupropion HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-013Bupropion HydrochlorideBupropion HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
43353-767Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
49999-349Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-918Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0785Bupropion HydrochlorideBupropion HydrochlorideA-S Medication SolutionsANDACurrent
50436-9101Bupropion HydrochlorideBupropion HydrochlorideUnit Dose ServicesANDACurrent
53808-0215Bupropion HydrochlorideBupropion HydrochlorideState of Florida DOH Central PharmacyANDACurrent
61919-037BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirectRXANDACurrent
61919-037BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirectRXANDACurrent
63187-416Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63629-2642Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2642Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-3233Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-3233Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63739-706Bupropion HydrochlorideBupropion HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-706Bupropion HydrochlorideBupropion HydrochlorideMcKesson CorporationANDACurrent
64725-1053Bupropion HydrochlorideBupropion HydrochlorideTYA PharmaceuticalsANDACurrent
66267-614Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-614Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67046-044Bupropion HydrochlorideBupropion HydrochlorideContract Pharmacy Services-PAANDACurrent
67046-045Bupropion HydrochlorideBupropion HydrochlorideContract Pharmacy Services-PAANDACurrent
67544-892Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68001-198Bupropion HydrochlorideBupropion HydrochlorideBluePoint LaboratoriesANDACurrent
68001-199Bupropion HydrochlorideBupropion HydrochlorideBluePoint LaboratoriesANDACurrent
68258-7001Bupropion HydrochlorideBupropion HydrochlorideDispensing Solutions, Inc.ANDACurrent
68788-9781Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals,Inc.ANDACurrent
68788-9781Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals,Inc.ANDACurrent
71335-0468Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0468Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23766ORIG2005-07-28
43006ORIG2001-06-07
30947ORIG2000-02-07