Application 200216

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200216-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2020-11-30

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
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	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-11-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A200216-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2020-11-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200216-001	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200216-001	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200216-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200216-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200216-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200216-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200216-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200216-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200216-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200216-001	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200216-001	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200216-001	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200216-001	AB3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A200216-001	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200216-001	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200216-001	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200216-001	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200216-001	AB3	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200216-001	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200216-001	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200216-001	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200216-001	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200216-001	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200216-001	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200216-001	AB3	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200216-001	AB3	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200216-001	AB3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200216-001	AB3	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200216-001	AB3	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200216-001	AB3	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200216-001	AB3	1	`cb3db0bc1861…`

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 9 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0eada89-e302-4ba3-bef0-e8c69af8206e	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2aabf040-16a6-b772-e063-6294a90afd70	2025-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8af7829-8b61-6785-e053-6294a90af052	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	57a9f4d3-0c41-4978-b81e-cf3059bc8c42	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29a6c6e3-f30f-6541-e063-6394a90ae11d	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	29848192-7de3-4c0d-a822-1268dcf128b0	2024-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	bb63261f-ad18-4885-9ed7-e7dfde33e171	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a724b3b6-f60e-4b88-8603-8141a32075da	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	0ac739de-ad59-4882-810e-f52db22ac96f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d6efb695-c439-48d7-a155-5c661a5049af	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Chartwell RX, LLC	620fab1e-aafb-444d-ab81-63281cd139c5	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	ec8c699f-a8de-4e5a-a223-8de3f5dfe20d	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7c46d95a-26f6-4364-8197-9e564e3405f2	2024-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	500fc18d-93b4-47d5-a3f7-3f68822d83e8	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	634bc654-be95-4fea-b308-eed53269a112	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	aef84c3a-68e2-e9d9-e053-2995a90a4ab8	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	0574b84d-075f-410f-a8eb-86901e307ea2	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	13560bf8-eb25-44f0-968e-db70d51219af	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-723	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-723	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-723	Bupropion hydrochloride	Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current