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 10 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEChartwell RX, LLC620fab1e-aafb-444d-ab81-63281cd139c52024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepackec8c699f-a8de-4e5a-a223-8de3f5dfe20d2024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack7c46d95a-26f6-4364-8197-9e564e3405f22024-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsaeb506f8-97c2-409a-aac9-5a73c840e8f32024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack500fc18d-93b4-47d5-a3f7-3f68822d83e82024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack634bc654-be95-4fea-b308-eed53269a1122024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.aef84c3a-68e2-e9d9-e053-2995a90a4ab82024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack0574b84d-075f-410f-a8eb-86901e307ea22024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LP13560bf8-eb25-44f0-968e-db70d51219af2024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEEpic Pharma LLC9fb44e96-6160-4a4a-90cb-91764c0dcd892024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDESlate Run Pharmaceuticals, LLC06d4d890-11ed-4f31-8778-c73432e3ea692024-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDESlate Run Pharmaceuticals, LLC7c4313fa-bb29-dd50-e053-2991aa0a30052024-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutions87dac2ee-732c-465b-8ffe-e5aeba4214252024-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions78ef709a-f835-4b03-92dd-16a4c82af0c12024-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutionsa18b5460-fcbb-42dd-8b87-197d11a089282024-05-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutions77b78d35-40f5-4713-8468-aa09a6c2925d2024-05-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: BUPROPION HYDROCHLORIDE
generic name: BUPROPION HYDROCHLORIDE
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe962fb9a-d9fb-49c5-a8b4-0b355b8f829b2024-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrochloride
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LPb59d950c-341f-45f1-b5b2-d64ccc7995802024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEA-S Medication Solutions339c7157-1c65-40d1-bbcc-c10348d908d32024-05-01Boxed 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.