Application 020358

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL50MGNoNo
002WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGYesNo
003WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGYesNo
004WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020358-001WELLBUTRIN SRBUPROPION HYDROCHLORIDE50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04
N020358-002WELLBUTRIN SRBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04
N020358-003WELLBUTRIN SRBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04
N020358-004WELLBUTRIN SRBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020358-002AB1
N020358-003AB1
N020358-004AB1

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-001WELLBUTRIN SR50MGTABLET, EXTENDED RELEASE / ORAL1996-10-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-002WELLBUTRIN SR100MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-003WELLBUTRIN SR150MGTABLET, EXTENDED RELEASE / ORALAB1RLD1996-10-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-004WELLBUTRIN SR200MGTABLET, EXTENDED RELEASE / ORALAB1RLD, RS2002-06-14d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020358-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020358-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N020358-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020358-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020358-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020358-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020358-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020358-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020358-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020358-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020358-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020358-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020358-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020358-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020358-004AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-003AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020358-004AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020358-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10N020358-003AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10N020358-004AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020358-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020358-003AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020358-004AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020358-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020358-003AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020358-004AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020358-002AB111e350fbaab3a…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WELLBUTRIN SRBUPROPION HYDROCHLORIDEGlaxoSmithKline LLCcbc8c074-f080-4489-a5ae-207b5fadeba32025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020358
application number: NDA020358
ndc (product): 0173-0135
ndc (product): 0173-0722
ndc (product): 0173-0947

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0135WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0722WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
0173-0947WELLBUTRINbupropion hydrochlorideGlaxoSmithKline LLCNDACurrent
70518-0639WELLBUTRINbupropion hydrochlorideREMEDYREPACK INC.NDACurrent
70518-0639WELLBUTRINbupropion hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84105SUPPL 2025-11-06
84104SUPPL 2025-11-06
84079SUPPL 2025-11-06
78427SUPPL 2024-05-08
78419SUPPL 2024-05-07
72875SUPPL2022-12-13
72819SUPPL2022-12-07
65002SUPPL2020-10-23
65001SUPPL2020-10-23
64972SUPPL2020-10-22
60831SUPPL2019-11-13
60830SUPPL2019-11-13
60801SUPPL2019-11-08
49480SUPPL2017-08-21
49458SUPPL2017-08-18
48360SUPPL2017-05-12
48352SUPPL2017-05-10
48304SUPPL2017-05-09
48265SUPPL2017-05-08
34548SUPPL2016-04-27
24832SUPPL2016-04-27
24831SUPPL2014-12-17
12474SUPPL2014-12-17
12475SUPPL2014-07-22
2385SUPPL2014-07-21
41299SUPPL2014-07-07
20610SUPPL2014-07-07
24830SUPPL2013-12-26
2384SUPPL2013-12-26
34547SUPPL2013-12-24
12473SUPPL2013-12-24
34546SUPPL2013-03-26
2383SUPPL2013-03-21
2382SUPPL2012-08-03
41298SUPPL2012-06-26
41297SUPPL2011-12-09
41296SUPPL2011-12-09
41295SUPPL2011-12-09
20607SUPPL2011-12-09
24829SUPPL2011-07-28
34545SUPPL2011-07-25
34544SUPPL2011-05-23
34540SUPPL2011-05-23
24828SUPPL2011-05-19
2378SUPPL2011-05-19
34543SUPPL2010-05-28
24826SUPPL2010-05-27
2381SUPPL2010-03-03
24827SUPPL2009-07-07
2380SUPPL2009-07-07
12472SUPPL2009-07-06
12471SUPPL2009-07-06
24825SUPPL2007-08-07
12470SUPPL2007-08-03
20609SUPPL2007-06-29
20608SUPPL2007-04-09
34542SUPPL2007-02-02
24824SUPPL2007-02-02
2379SUPPL2006-07-13
2377SUPPL2006-07-13
34541SUPPL2006-07-05
34539SUPPL2006-07-05
2376SUPPL2006-03-03
23578ORIG2005-07-28
24823SUPPL2005-01-13
12469SUPPL2005-01-13
2375SUPPL2004-06-01
24822SUPPL2004-04-29
2374SUPPL2002-10-22
24819SUPPL2002-10-02
2372SUPPL2002-10-02
24821SUPPL2002-07-12
2373SUPPL2002-06-20
24820SUPPL2002-06-14
12468SUPPL2002-06-14
34538SUPPL2001-06-11
24818SUPPL2001-06-11
20606SUPPL2001-06-11
41294SUPPL1997-12-16
20605SUPPL1997-12-16