Application 208652

Type
ANDA
Sponsor
SINOTHERAPEUTICS 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 42.

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
A208652-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21
A208652-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208652-001AB3
A208652-002AB3

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208652-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A208652-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208652-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208652-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208652-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208652-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208652-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208652-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208652-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208652-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208652-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208652-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208652-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208652-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208652-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208652-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208652-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208652-002AB31bb7c543d1eb4…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEMullan Pharmaceutical Inc.75b1e027-4c5d-46e5-98ee-033e67bd411c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
Bupropion hydrochloride (XL)BUPROPION HYDROCHLORIDELannett Company Inc.15c4e95a-d203-4caf-b6c7-44792355cb762025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
ndc (product): 0527-2430
ndc (product): 0527-2415
Bupropion hydrochloride (XL)BUPROPION HYDROCHLORIDEVitruvias Therapeuticsf53704b2-3d3c-47e8-9fd6-a0f5240c05932025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
BUPROPION HYDROCHLORIDE (XL)BUPROPION HYDROCHLORIDE (XL)Chartwell RX, LLC8d9779e7-300e-4720-8ba5-2272b2506cd92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-2415Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2415Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2430Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2430Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
50090-4169Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-4169Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6173Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6173Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6258Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
53002-1508Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1508Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2495Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
68788-7347Bupropion hydrochloride (XL)Bupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7347Bupropion hydrochloride (XL)Bupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-723Bupropion hydrochloride (XL)Bupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-724Bupropion hydrochloride (XL)Bupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-045Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-045Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1542Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1542Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent