Application 090325

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No
003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090325-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08
A090325-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08
A090325-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090325-001	AB1
A090325-002	AB1
A090325-003	AB1

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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090325-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090325-002	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090325-003	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090325-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090325-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090325-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-003	AB1	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A090325-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090325-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090325-003	AB1	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090325-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090325-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090325-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090325-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090325-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090325-003	AB1	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-003	AB1	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090325 application number: ANDA090325

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3411	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3411	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
0378-3412	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3412	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
0378-3413	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3413	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
51079-391	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-392	Bupropion hydrochloride	Bupropion hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-4392	Bupropion hydrochloride	Bupropion hydrochloride	Cardinal Health, Inc.	ANDA	Current
55154-4392	Bupropion hydrochloride	Bupropion hydrochloride	Cardinal Health, Inc.	ANDA	Current
71335-0783	Bupropion hydrochloride	Bupropion hydrochloride	Bryant Ranch Prepack	ANDA	Current