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N020711-003ZYBANBUPROPION HYDROCHLORIDE150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14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2026-09-14 22:38:342026-08N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-1484e616aacf4f…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2026-08-18 06:07:402026-07N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14caaa826d4ba7…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2026-02-19 14:30 UTC2026-02N020711-003ZYBAN150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1997-05-14011fe1cb6892…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 1 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEApotex Corp86530199-999b-9f92-b1bc-b8515ec829f32026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.136f29fa-a859-4efb-8365-1382716d6f8f2026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.81d251aa-a8e8-493e-94ed-12f6fb8902e62026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEGranules Pharmaceuticals Inc.d9eb0939-63c1-48c4-a444-a899d7924d062026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0b041720-a25d-403e-a72c-601a8bdd80512026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.b47c5515-a438-40bc-b8ad-26a6cf9676b72026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.6087100f-3ba4-412e-b08d-768d1dcdaf002026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0aa86bd6-b37b-45f7-a837-b067e41184e92026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.bcbef1b4-a135-4231-bc65-7d0b335260e82026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEQuallent Pharmaceuticals Health LLC56df4e22-81ca-48a4-a8e2-0384484173552026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5f8b3313-0286-499f-9235-02cdc0eb063b2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC334e5635-e4cc-cf2a-e063-6294a90ae1e12026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEREMEDYREPACK INC.0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c42026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5829a2aa-4845-b58b-e063-6294a90ad2f42026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEREMEDYREPACK INC.4cc3327b-92c5-4667-ae16-3e95eafcf4d82026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.30c370c2-f2b7-4335-ba55-e8c8f40590922026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEREMEDYREPACK INC.080853c0-fcab-4645-9ddc-4946e895ac5f2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsaa3d3e5b-74a3-47f6-b9aa-d6e248e950e52026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAurobindo Pharma Limitedcc344f7c-0eb3-4e63-a09e-b682acca2bb52026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE

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