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 12 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LP4a2be6af-e256-4fa9-bfa9-5300d52cdaf42020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LPa165869a-9bc4-4987-babe-a77fad78c38f2020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPd4272e3f-78ee-4d80-b911-e840fb14acbe2019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE (SR)BUPROPION HYDROCHLORIDECipla USA Inc.,9d2c209b-248e-4e26-9cde-fe0abe4428c12018-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDESun Pharmaceutical Industries, Inc.e4e38abf-ef67-405b-af2d-3d8e4533654d2018-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7d81ed30-ddf7-431a-84f8-6c630cf2b9772018-10-18Boxed 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.