Application 073137

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

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
002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A073137-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24
A073137-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24
A073137-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073137-001	AB
A073137-002	AB
A073137-003	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 4 · 126 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	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-002	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1993-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1995-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1993-03-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A073137-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073137-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073137-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073137-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073137-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073137-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073137-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073137-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073137-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073137-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073137-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073137-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073137-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073137-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073137-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073137-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073137-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073137-001	AB	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	55f18806-6c23-783b-e063-6294a90acc46	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	4c4ca53e-9201-298c-e063-6294a90a72c6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fa7afa93-b98c-4dc7-bbb8-ab6a058427b9	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	f291b905-a739-5e43-e053-2995a90ac40c	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073137 application number: ANDA073137

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2211	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2393	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2529	Trazodone Hydrochloride	Trazodone Hydrochloride	A-S Medication Solutions	ANDA	Current
53489-510	Trazodone Hydrochloride	Trazodone Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-511	Trazodone Hydrochloride	Trazodone Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-517	Trazodone Hydrochloride	Trazodone Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
66116-357	Trazodone Hydrochloride	Trazodone Hydrochloride	MedVantx, Inc.	ANDA	Current
70518-1287	Trazodone Hydrochloride	Trazodone Hydrochloride	REMEDYREPACK INC.	ANDA	Current