Application 216766

Type
ANDA
Sponsor
YICHANG HUMANWELL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216766-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216766-001AB2

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
2026-02-19 14:30 UTC2026-02A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-093bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216766-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB22023-01-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216766-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216766-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216766-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216766-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216766-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216766-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216766-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216766-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216766-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216766-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216766-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216766-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216766-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216766-001AB218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216766-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216766-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216766-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216766-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216766-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216766-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216766-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A216766-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A216766-001AB213bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216766-001AB21a50c72e98297…

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
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEEpic Pharma, LLCf56ccdb1-f9d9-3e5f-e053-2995a90a8f162026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216766
application number: ANDA216766