FDA.reportPublic FDA data

Application 020711

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ZYBANBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoNo
003ZYBANBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020711-002ZYBANBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14
N020711-003ZYBANBUPROPION HYDROCHLORIDE150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-1484e616aacf4f…
2026-09-14 22:38:342026-08N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-1484e616aacf4f…
2026-08-18 06:07:402026-07N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020711-003ZYBAN150MGTABLET, EXTENDED RELEASE / ORALRLD1997-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020711-003ZYBAN150MGTABLET, EXTENDED RELEASE / ORALRLD1997-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020711-003ZYBAN150MGTABLET, EXTENDED RELEASE / ORALRLD1997-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020711-002ZYBAN100MGTABLET, EXTENDED RELEASE / ORAL1997-05-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020711-003ZYBAN150MGTABLET, EXTENDED RELEASE / ORALRLD1997-05-1474a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N020711-003AB21ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAsclemed USA, Inc.637e89e5-8f6e-4392-8045-a778cb9ed1382025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.5dec4414-5595-46c9-ada9-3fbe981520402025-02-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC2ccbf988-64b6-3a60-e063-6394a90ababa2025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.d1043c87-0abe-ee8e-e053-2a95a90a419a2025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.1724f474-d6ab-46af-940f-7f874d4ff7fc2025-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4971c3cb-07c4-4c65-a16a-f1700e5231472025-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackbd99969d-03d5-4609-88e8-a9ae93a839072025-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.0e8b2109-8516-2d92-e063-6394a90a5d162025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0eada89-e302-4ba3-bef0-e8c69af8206e2025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2aabf040-16a6-b772-e063-6294a90afd702025-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8af7829-8b61-6785-e053-6294a90af0522024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEQuality Care Products, LLC57a9f4d3-0c41-4978-b81e-cf3059bc8c422024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29a6c6e3-f30f-6541-e063-6394a90ae11d2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDESun Pharmaceutical Industries, Inc.29848192-7de3-4c0d-a822-1268dcf128b02024-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBluePoint Laboratories5ccec958-998d-43a1-86fb-eb2b5e697b772024-11-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsbb63261f-ad18-4885-9ed7-e7dfde33e1712024-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa724b3b6-f60e-4b88-8603-8141a32075da2024-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutions0ac739de-ad59-4882-810e-f52db22ac96f2024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutionsd6efb695-c439-48d7-a155-5c661a5049af2024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0556ZYBANbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0556ZYBANbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0556ZYBANbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66743SUPPL2021-03-11
66742SUPPL2021-03-11
66711SUPPL2021-03-10
59397SUPPL2019-07-22
59396SUPPL2019-07-22
59394SUPPL2019-07-22
48294SUPPL2017-05-09
48293SUPPL2017-05-09
48292SUPPL2017-05-09
48251SUPPL2017-05-05
48250SUPPL2017-05-05
48249SUPPL2017-05-05
35204SUPPL2016-06-02
25610SUPPL2016-06-02
13273SUPPL2015-01-09
25608SUPPL2014-12-30
35203SUPPL2014-08-15
25609SUPPL2014-08-14
13272SUPPL2014-04-01
3173SUPPL2014-03-28
35202SUPPL2012-02-01
3172SUPPL2012-01-20
3171SUPPL2011-08-26
3167SUPPL2011-08-26
35200SUPPL2011-08-22
13271SUPPL2011-08-22
25606SUPPL2010-09-23
35201SUPPL2010-09-20
3170SUPPL2010-03-03
13270SUPPL2009-07-09
13269SUPPL2009-07-09
25607SUPPL2009-07-08
3169SUPPL2009-07-08
25605SUPPL2007-08-07
13268SUPPL2007-08-03
41605SUPPL2007-07-09
13267SUPPL2007-03-23
3168SUPPL2007-03-23
25604SUPPL2006-11-22
13266SUPPL2006-11-22
20870SUPPL2006-05-16
20869SUPPL2006-05-16
25603SUPPL2006-05-02
25602SUPPL2006-04-07
23594ORIG2005-07-28
13265SUPPL2005-01-13
3166SUPPL2005-01-13
35199SUPPL2004-11-08
25601SUPPL2004-11-08
13264SUPPL2004-11-08
3165SUPPL2004-11-08
35198SUPPL2004-07-01
35197SUPPL2004-07-01
35196SUPPL2004-07-01
25600SUPPL2004-07-01
25598SUPPL2004-07-01
13263SUPPL2004-07-01
3164SUPPL2004-07-01
3163SUPPL2004-07-01
20868ORIG2003-08-08
25599SUPPL2002-02-21
41604SUPPL2001-02-07
35195SUPPL2001-02-07
25597SUPPL2001-02-07