Application 203013

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203013-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2018-06-08
A203013-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203013-001	AB
A203013-002	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203013-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	990587bd-4c7d-4a36-8a38-3104648ab3a2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	b303a0ad-5971-44ab-937c-bcf3ff650358	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ef0bb8f2-7710-4236-8b47-57b74c8bca3e	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013 ndc (product): 46708-127 ndc (product): 46708-118

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-118	Bupropion Hydrochloride	Bupropion Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-118	Bupropion Hydrochloride	Bupropion Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-127	Bupropion Hydrochloride	Bupropion Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-127	Bupropion Hydrochloride	Bupropion Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
64980-201	Bupropion Hydrochloride	Bupropion Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-202	Bupropion Hydrochloride	Bupropion Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
68071-5213	Bupropion Hydrochloride	Bupropion Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5213	Bupropion Hydrochloride	Bupropion Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1551	Bupropion Hydrochloride	Bupropion Hydrochloride	Bryant Ranch Prepack	ANDA	Current