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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077285-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26
A077285-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077285-001AB3
A077285-002AB3

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26a50c72e98297…
2026-08-01 22:54:322026-06A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077285-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A077285-002AB31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEActavis Pharma, Inc.df923448-4f81-47af-8e55-f7359746b05f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
ndc (product): 45963-142
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEHAWAII REPACK, INC.b4a1d3b8-afcf-47e3-96d3-469d8f408a312025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAsclemed USA, Inc.637e89e5-8f6e-4392-8045-a778cb9ed1382025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LP9e2d9c1e-a1de-491d-8f64-34ae604196112022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
ndc (product): 63187-819

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

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