FDA.reportPublic FDA data

Application 077285

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-749Bupropion HydrochlorideBupropion Hydrochloridemedsource pharmaceuticalsANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
45963-142Bupropion HydrochlorideBupropion HydrochlorideActavis Pharma, Inc.ANDACurrent
50090-2721Bupropion HydrochlorideBupropion HydrochlorideA-S Medication SolutionsANDACurrent
53002-2508Bupropion HydrochlorideBupropion HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-254Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-257Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-358Bupropion HydrochlorideBupropion HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-358Bupropion HydrochlorideBupropion HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-358Bupropion HydrochlorideBupropion HydrochlorideGolden State Medical SupplyANDACurrent
63187-728Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63187-819Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63187-819Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63187-819Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63187-819Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
63187-819Bupropion HydrochlorideBupropion HydrochlorideProficient Rx LPANDACurrent
68788-7221Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7221Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7221Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0227Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-758Bupropion HydrochlorideBupropion HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0331Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0331Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0331Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71610-131Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22600ORIG2011-08-09