Application 210015

Type
ANDA
Sponsor
YICHANG HUMANWELL

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
A210015-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14
A210015-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210015-001AB3
A210015-002AB3

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210015-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A210015-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32018-06-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210015-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210015-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210015-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210015-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210015-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210015-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210015-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210015-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210015-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210015-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210015-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210015-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210015-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210015-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210015-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210015-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210015-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210015-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210015-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210015-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210015-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210015-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210015-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210015-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210015-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210015-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210015-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210015-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210015-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210015-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210015-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210015-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210015-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210015-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210015-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210015-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210015-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210015-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210015-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A210015-002AB31782e0a99824c…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.eb946d81-b4f4-42e9-aa7a-31d76d15629c2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9aa3753f-1a0e-4faa-995f-67e29b3207372026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionsb2e6c30f-a33c-4854-ab19-bc9f658803742026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.02275c51-6b3e-434a-bdb5-99135e73f1a42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEBryant Ranch Prepackeb25adb1-9841-42ce-aa22-718fb0fba5dd2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEEpic Pharma, LLCf79d1422-a9b6-41c2-a46d-22886605f94d2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDESlate Run Pharmaceuticals, LLC06d4d890-11ed-4f31-8778-c73432e3ea692024-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
ndc (product): 70436-010
ndc (product): 70436-011
Bupropion HCL ER (XL)BUPROPION HCL ER (XL)Direct_RX129ce80c-0333-873e-e063-6394a90a33e02024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmacueticals, Inc.15ad0c66-1829-59c3-e063-6394a90a43842024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LPdfd5f264-d4fd-4441-88b1-48086c7c06162024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LP4a2be6af-e256-4fa9-bfa9-5300d52cdaf42020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210015
application number: ANDA210015
ndc (product): 71205-394

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8416Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8418Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-7084Bupropion Hydrochloridebupropion hydrochlorideMajor PharmaceuticalsANDACurrent
0904-7084Bupropion Hydrochloridebupropion hydrochlorideMajor PharmaceuticalsANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-010Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-011Bupropion Hydrochloridebupropion hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70518-2332Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2332Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2332Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2332Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2332Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2634Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2634Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2634Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2634Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2634Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2637Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-804Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-804Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-394Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent