Application 076143

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL75MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL100MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076143-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17
A076143-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076143-001AB
A076143-002AB

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1784e616aacf4f…
2026-09-14 22:38:342026-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1784e616aacf4f…
2026-08-18 06:07:402026-07A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076143-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2006-01-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076143-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALABRS2006-01-1774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076143-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076143-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A076143-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076143-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076143-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076143-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076143-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076143-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076143-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076143-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076143-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076143-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076143-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076143-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076143-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076143-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076143-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076143-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076143-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076143-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076143-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076143-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076143-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076143-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076143-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076143-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076143-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076143-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076143-002AB174a2ff9319b5…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEApotex Corp86530199-999b-9f92-b1bc-b8515ec829f32026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5829a2aa-4845-b58b-e063-6294a90ad2f42026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.867d3876-6974-4e89-bc45-9e60e84b401c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
ndc (product): 72789-070
Bupropion HydrochlorideBUPROPION HYDROCHLORIDESt. Mary's Medical Park Pharmacy362504fd-2f0a-c097-e063-6394a90ac0fc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging88c980c8-aaa8-4378-9ac2-24d588640caa2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b5c12c9a-62eb-481a-8099-7ad35242f7bf2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLC64934ca2-5655-45a2-9016-ad65b5abf5d32026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5038440c-1f32-715a-e063-6294a90a889d2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLCec4d2256-0340-4166-90ee-c264eef3ac822026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.eabb54b7-164c-4de8-b91a-f2e65637b5fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
ndc (product): 68788-7988
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsb127d3fc-be5e-4c12-8026-205766bf8e7f2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAvPAKbcb4ef83-f272-4090-8547-9aaf4ab636672026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBluePoint Laboratories7d035056-44ab-444d-9d27-125b3f5711402025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEGolden State Medical Supply, Inc.9490d611-b679-45c7-e053-2a95a90afb872025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackf566f8b5-b3c1-4234-88bd-59a7b8dc801a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackfa5fa0d8-d27f-44e1-8868-dfa7206524e22025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack2a13267f-c47f-4791-a8f9-4bbb5c8040272025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
ndc (product): 71335-0182
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack1d722dc2-7909-454e-b989-0956770790442025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
ndc (product): 71335-0013
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.d1043c87-0abe-ee8e-e053-2a95a90a419a2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143
ndc (product): 68071-2577
Bupropion HCLBUPROPION HCLDirect_Rxf820ad7d-3c88-4a4f-e053-6294a90aef7b2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076143
application number: ANDA076143

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 111 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-2256Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2577Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6994Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7988Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7988Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1566Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1584Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0013Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0013Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0013Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0013Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0182Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0182Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0182Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0182Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
71610-164Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-372Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-384Bupropion HydrochlorideBupropion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-070Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-070Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-070Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44290ORIG2006-02-15