FDA.reportPublic FDA data

Application 220529

Type
ANDA
Sponsor
YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220529-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04
A220529-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04
A220529-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220529-001AB1
A220529-002AB1
A220529-003AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220529-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12026-05-0484e616aacf4f…
2026-09-14 22:38:342026-08A220529-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12026-05-0484e616aacf4f…
2026-09-14 22:38:342026-08A220529-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12026-05-0484e616aacf4f…
2026-08-18 06:07:402026-07A220529-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A220529-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A220529-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12026-05-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220529-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A220529-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A220529-003AB1184e616aacf4f…
2026-08-18 06:07:402026-07A220529-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A220529-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A220529-003AB11caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220529-003AB11a50c72e98297…

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 7 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions722650d8-5ee4-48ba-9827-7c86b12835222025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions16ffe2ac-4f71-4843-99df-611f53c2f3cd2025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f72025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAccord Healthcare Inc.34686e9d-c106-4276-8b47-7460cca8860e2025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE (SR)BUPROPION HYDROCHLORIDEDr. Reddy's Laboratories Inc8069c521-c49a-4b6d-baa8-4b0be897d5852025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAurobindo Pharma Limited6563b923-269f-40c3-b992-cbacdfca6e162025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC3eec57be-b8ae-cdf8-e063-6394a90a694d2025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAlembic Pharmaceuticals Inc.b303a0ad-5971-44ab-937c-bcf3ff6503582025-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9196568e-aec8-4d56-993e-4cbb78d4a3a62025-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.069e6828-e599-4614-9645-9cf1382ac93e2025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochlorideBUPROPION HYDROCHLORIDEUpsher-Smith Laboratories, LLC98d5977f-9b32-46db-bd36-a2c4d1b0710a2025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3d826804-6427-aae1-e063-6394a90a65932025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.d087222e-c5e9-4c48-b27f-e2e2944379c82025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.eeb3fed1-2202-09fc-e053-2995a90a9f632025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackf566f8b5-b3c1-4234-88bd-59a7b8dc801a2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackfa5fa0d8-d27f-44e1-8868-dfa7206524e22025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa0fdfc21-165a-43fa-9b3c-e48f3b8922502025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionseee88553-acff-4bdd-acd1-f39bcb6fcdca2025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack2a13267f-c47f-4791-a8f9-4bbb5c8040272025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack1d722dc2-7909-454e-b989-0956770790442025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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