FDA.reportPublic FDA data

Application 207874

Type
ANDA
Sponsor
IPCA LABS LTD

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
A207874-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02
A207874-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02
A207874-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207874-001AB1
A207874-002AB1
A207874-003AB1

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 22:38:342026-08A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0284e616aacf4f…
2026-09-14 22:38:342026-08A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0284e616aacf4f…
2026-09-14 22:38:342026-08A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0284e616aacf4f…
2026-08-18 06:07:402026-07A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12025-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207874-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A207874-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A207874-003AB1184e616aacf4f…
2026-08-18 06:07:402026-07A207874-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A207874-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A207874-003AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207874-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207874-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207874-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207874-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207874-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207874-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207874-003AB116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207874-003AB11a50c72e98297…

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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEA-S Medication Solutions73167de9-948d-465c-88c0-c7743a79e7f52024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEA-S Medication Solutions6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e2024-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmacueticals, Inc.15ad0c66-1829-59c3-e063-6394a90a43842024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackc1fa6fce-272b-4497-a958-177f0bafdfc72024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutions62d0dcb5-c70b-4884-9755-740f62a8b31a2024-03-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutions8ae81b03-b447-4a3f-8ed9-ebf75ee52b492024-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LPdfd5f264-d4fd-4441-88b1-48086c7c06162024-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8d80f882-1887-4d73-b09f-e98fd7ef2acb2024-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAlembic Pharmaceuticals Limitedef0bb8f2-7710-4236-8b47-57b74c8bca3e2024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEA-S Medication Solutionsdfb45438-1116-48f2-9bfe-776ebbf1e1192023-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECipla USA., Inc.0abd64f7-5142-48f6-a487-3f5bdc3400de2023-10-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEProficient Rx LP80f4a4ef-8190-458d-af2e-5daaf32abc012023-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b2023-08-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LPec9cbb38-1582-492f-a526-4b3675c55b142023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEExelan Pharmaceuticals Inc.8a0781c0-e7d5-498e-b7d3-d6bd457f175f2023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutionsef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a2023-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb0e10a21-0ae3-4a8b-bd3e-7a48b30f84182023-05-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDECIPLA USA INC.,e4100232-a25d-4468-9057-af7e662051542023-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEDr. Reddys Laboratories Inc.6948f63b-599c-4956-a249-e9544beda9fc2022-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LP5e568bb5-542a-4395-a21e-dc64281d694e2022-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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