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 3 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack82bcdd72-9146-4c8d-a8aa-f920158646052026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackaf5b1cc8-f078-4a7b-b64a-4cb2de1e57212026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEBryant Ranch Prepackeb25adb1-9841-42ce-aa22-718fb0fba5dd2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack8499470a-8d01-4348-b67b-8f49728031cb2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack5c111cf0-0199-4a4d-8138-81579af4c14d2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4c9a5dc3-bebe-431a-b550-ce46c6c6b01e2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEUnit Dose Solutions, Inc.53c192ca-ac51-cb87-e063-6394a90a6c082026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPf1703bfd-be36-4fde-8e67-df0fb5d933692026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepackcefaaa17-f79a-4ba6-8f97-a59f60e07b752026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f58ce435-b124-4519-98d8-de2d00f61b012026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b5c12c9a-62eb-481a-8099-7ad35242f7bf2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack6701af43-bf7d-45c4-a331-a18d16bd68f72026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmici Pharma, Inc.fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c752026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack21be6b3b-add3-43e7-af93-30350aefc89e2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepacka72db723-df4b-4bf4-9bdc-05ae820586962026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDECoupler LLC512b0ed3-db7d-b273-e063-6394a90a25cc2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC507112bd-a082-e85a-e063-6294a90ab2ac2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLC64934ca2-5655-45a2-9016-ad65b5abf5d32026-04-24Boxed 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.