Application 072193

Type: ANDA
Sponsor: OXFORD PHARMS

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 42.

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
A072193-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072193-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A072193-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072193-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072193-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072193-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072193-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072193-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072193-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072193-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072193-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072193-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072193-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072193-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	AB	1	`e64feba35796…`

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
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072193 application number: ANDA072193

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
0603-6161	Trazodone Hydrochloride	Trazodone Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-6161	Trazodone Hydrochloride	Trazodone Hydrochloride	Par Pharmaceutical	ANDA	Current
43353-653	Trazodone Hydrochloride	Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
55700-274	Trazodone Hydrochloride	Trazodone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-434	Trazodone Hydrochloride	Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-384	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-377	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
63187-377	Trazodone Hydrochloride	Trazodone Hydrochloride	Proficient Rx LP	ANDA	Current
67046-742	Trazodone Hydrochloride	Trazodone Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
68387-166	Trazodone Hydrochloride	Trazodone Hydrochloride	Keltman Pharmaceuticals Inc.	ANDA	Current
70518-0160	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current