Application 071524

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAZODONE HYDROCHLORIDE	TRAZODONE 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071524-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071524-001	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 2 · 43 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	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-12-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A071524-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071524-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071524-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071524-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071524-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071524-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071524-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071524-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071524-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071524-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071524-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071524-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071524-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071524-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071524-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071524-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071524-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071524-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071524-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071524-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071524-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071524-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071524-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071524-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071524-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071524-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071524-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071524-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071524-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071524-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071524-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071524-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071524-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071524-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071524-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071524-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071524-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071524-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071524-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071524-001	AB	1	`f41ea6bd6efb…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524 ndc (product): 70518-2973
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	df17cec9-ad5e-4e57-8572-c927c9b955e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	b3723265-7455-c25c-e053-2a95a90a379b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b617348c-cb19-45df-b313-4ea6af6f1dda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Northwind Health Company, LLC	e07d7ee3-776d-1fa3-e053-2a95a90a7019	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524 ndc (product): 71610-537
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5ab590d8-225f-43f4-bb68-1f2c86f9a886	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524 ndc (product): 71610-530
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4006d439-e2de-4590-82e9-fc9d56e3ec1b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	203881a3-37d0-41dd-86c5-1e53fb784326	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071524 application number: ANDA071524 ndc (product): 71205-574

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 2 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1494	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1494	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2973	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2973	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2973	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2973	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-437	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-749	Trazodone Hydrochloride	Trazodone Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-574	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
71610-530	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-530	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-537	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-537	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current