Application 207403

Type: ANDA
Sponsor: MICRO LABS

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 43.

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
A207403-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			2020-04-17
A207403-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			2020-04-17

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 2 · 78 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
2026-09-14 22:38:34	2026-08	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2020-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2020-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207403-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2020-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207403-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-04-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207403-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207403-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207403-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207403-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207403-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207403-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207403-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207403-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207403-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207403-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207403-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207403-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207403-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207403-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207403-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207403-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207403-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207403-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207403-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207403-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207403-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207403-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207403-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207403-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207403-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207403-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207403-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207403-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207403-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207403-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207403-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207403-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207403-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207403-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207403-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207403-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207403-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207403-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207403-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207403-002	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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Asclemed USA, Inc.	d1d0872c-5b11-4e13-a401-b122348e0fa7	2026-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e4f4d3fa-ddf6-4125-8486-8157efc095c1	2026-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d86e26e0-6e10-4d59-8cc8-94b551774b86	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	b127d3fc-be5e-4c12-8026-205766bf8e7f	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	f79d1422-a9b6-41c2-a46d-22886605f94d	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	f56ccdb1-f9d9-3e5f-e053-2995a90a8f16	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4bd469b8-fb35-0223-e063-6294a90ae7bc	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	bcb4ef83-f272-4090-8547-9aaf4ab63667	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d0608a1-0cc8-491a-ad91-238e0ea009fe	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	ad784c8e-7201-4336-a310-616e3e979ca4	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
WELLBUTRIN XL	BUPROPION HYDROCHLORIDE	Bausch Health US LLC	a435da9d-f6e8-4ddc-897d-8cd2bf777b21	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	039d4368-c764-463a-b0cd-1cac702b8fb2	2026-02-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	6902b252-dc69-4b3c-bad2-b6667a5f6d84	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	16a788ff-8bd5-4f70-a3fd-a89db019e435	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals,Inc.	05f82eca-cc87-4580-acd7-e6491c651881	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Mullan Pharmaceutical Inc.	75b1e027-4c5d-46e5-98ee-033e67bd411c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	4956af38-182a-4015-a945-67e40bd38772	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	093c4a61-02d9-4b55-b612-569aa25d3f2a	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	092da413-ec60-4577-ac57-51e3e42d55c9	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE

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 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-241	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current
42571-241	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current
42571-241	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current
42571-242	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current
42571-242	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current
42571-242	BUPROPION HYDROCHLORIDE	Bupropion Hydrochloride	Micro Labs Limited	ANDA	Current