Application 206975

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL75MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL100MGNoNo

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

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
A206975-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19
A206975-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206975-001AB
A206975-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206975-001BUPROPION HYDROCHLORIDE75MGTABLET / ORALAB2016-08-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A206975-002BUPROPION HYDROCHLORIDE100MGTABLET / ORALAB2016-08-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206975-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206975-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206975-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206975-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206975-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206975-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206975-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206975-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206975-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206975-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206975-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206975-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206975-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206975-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206975-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206975-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206975-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206975-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206975-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206975-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206975-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206975-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206975-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206975-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206975-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206975-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206975-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206975-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206975-002AB1782e0a99824c…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
ndc (product): 43063-994
bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC507112bd-a082-e85a-e063-6294a90ab2ac2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMAJOR PHARMACEUTICALS3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c92026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.90cc4f07-e0a3-4d50-a10a-8f6a7f9c51402026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDENorthwind Health Company, LLCd9bbacb3-63b4-2922-e053-2a95a90a60852026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacke2a988f2-f8d3-4de0-b9f1-49d8c2e4180f2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacke4c450ff-32bd-4359-8449-0b0d0b89a78c2025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC3eec57be-b8ae-cdf8-e063-6394a90a694d2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9196568e-aec8-4d56-993e-4cbb78d4a3a62025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
ndc (product): 23155-192
ndc (product): 23155-191
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack744f7394-aac9-4864-9436-e5b0b35a61482025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack144379e1-93b7-41c1-bc3a-7bdec5afa3092025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
ndc (product): 71335-0791
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC35a873c5-4aa8-b3c7-e063-6394a90a35ec2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC334e5635-e4cc-cf2a-e063-6294a90ae1e12025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4971c3cb-07c4-4c65-a16a-f1700e5231472025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackbd99969d-03d5-4609-88e8-a9ae93a839072025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0eada89-e302-4ba3-bef0-e8c69af8206e2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEChartwell RX, LLC620fab1e-aafb-444d-ab81-63281cd139c52024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206975
application number: ANDA206975

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8261bupropion Hydrochloridebupropion HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8261bupropion Hydrochloridebupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8261bupropion Hydrochloridebupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8296bupropion Hydrochloridebupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8296bupropion Hydrochloridebupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-191bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-192bupropion Hydrochloridebupropion HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
43063-994bupropion Hydrochloridebupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-994bupropion Hydrochloridebupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-994bupropion Hydrochloridebupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-994bupropion Hydrochloridebupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-0191bupropion Hydrochloridebupropion HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0191bupropion Hydrochloridebupropion HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0191bupropion Hydrochloridebupropion HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
68071-4961bupropion Hydrochloridebupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4961bupropion Hydrochloridebupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2934bupropion Hydrochloridebupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2934bupropion Hydrochloridebupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-704bupropion Hydrochloridebupropion HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0791bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0791bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0791bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0791bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-1192bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-1192bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-1192bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-1192bupropion Hydrochloridebupropion HydrochlorideBryant Ranch PrepackANDACurrent