Application 022411

Type: NDA
Sponsor: ANGELINI PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLEPTRO	TRAZODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	OLEPTRO	TRAZODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N022411-001	OLEPTRO	TRAZODONE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2010-02-02
N022411-002	OLEPTRO	TRAZODONE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2010-02-02

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06
N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16
N022411-002	7829120	2027-03-27	U-796	Drug product
N022411-002	8133893	2029-03-13		Drug substance, Drug product

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022411-001	OLEPTRO	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022411-002	OLEPTRO	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-02	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022411-002	7829120	2027-03-27	U-796	Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022411-002	7829120	2027-03-27	U-796	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022411-002	7829120	2027-03-27	U-796	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022411-002	7829120	2027-03-27	U-796	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022411-002	7829120	2027-03-27	U-796	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022411-002	7829120	2027-03-27	U-796	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022411-002	7829120	2027-03-27	U-796	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022411-002	7829120	2027-03-27	U-796	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022411-002	7829120	2027-03-27	U-796	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022411-001	7829120	2027-03-27	U-796	Drug product	2010-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022411-001	8133893	2029-03-13		Drug substance, Drug product	2012-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022411-002	7829120	2027-03-27	U-796	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022411-002	8133893	2029-03-13		Drug substance, Drug product		`2680178bc6a6…`

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 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fa7afa93-b98c-4dc7-bbb8-ab6a058427b9	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	TRUPHARMA LLC	a57da4f8-151d-4a74-8710-6158d1da3852	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	3b2e61b0-414c-48ae-9e13-06470c302c67	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	596c3f00-1504-eaed-e063-6294a90a08bb	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	American Health Packaging	f715085a-be56-497e-ad92-9fec3aba70b5	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1f74b23d-f2eb-4c18-a583-d608b7713694	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	dc1f347e-1acb-4c06-b36e-f15fecb7ac93	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	acd077db-e2b8-4d29-94c0-128439050c66	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	81a5b557-06f6-2470-e053-2991aa0a64fd	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	a31d59ed-5949-4f85-8b73-3bfd7f72d5b8	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	51012256-b249-ccbb-e063-6394a90af4fa	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	2863317d-657b-4dc6-81fb-b7158ea03498	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	007f38e0-653b-43e4-a1c1-b59997b2762a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	68bcae4b-f4c3-4d28-af76-d182b707fc73	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fa890-0a39-9361-e063-6294a90a1bb5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fdfb9-c060-63bc-e063-6294a90ad840	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	04c287ca-5efa-469d-ab39-ff16d9b1e0b3	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAZODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
38675	SUPPL	2014-07-22
7350	SUPPL	2014-07-21
17558	SUPPL	2012-11-15
7349	SUPPL	2012-11-14
29700	SUPPL	2011-05-10
38674	SUPPL	2011-05-06
44749	ORIG	2010-07-27
42516	ORIG	2010-07-27
7348	ORIG	2010-02-05
23396	ORIG	2010-02-04
17557	ORIG	2010-02-04