Application 211116

Type: ANDA
Sponsor: CROSSMEDIKA SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No
004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211116-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20
A211116-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20
A211116-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20
A211116-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211116-001	AB
A211116-002	AB
A211116-003	AB
A211116-004	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 · 64 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	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A211116-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211116-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211116-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211116-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211116-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211116-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211116-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211116-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211116-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211116-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211116-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211116-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211116-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211116-004	AB	1	`5bbf6a4d5a75…`

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 4 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	Preferred Pharmaceuticals Inc.	9962589c-ee1f-4d5e-bd49-b7807bb60ace	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	4370fe5c-1c40-499b-abb5-bca0a39834c6	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a343910a-bf4c-4a41-b0ee-0e90e8355815	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	1514b3b0-7742-4247-b9fd-ea14849d3fdd	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d42fd0c8-3673-4f18-a6c0-cd276bbf9fef	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f7e6a78e-7ac3-35b9-e053-6294a90aabd0	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5ab590d8-225f-43f4-bb68-1f2c86f9a886	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Major Pharmaceuticals	8eb85c26-a6cb-4a10-a990-ccc0b20aff08	2025-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4006d439-e2de-4590-82e9-fc9d56e3ec1b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Cardinal Health 107, LLC	9265f4f6-df24-4495-9dbf-e3fcfa4c864d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	42ecd35c-4300-4cd3-942a-f3efb872fa99	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	adc7427e-3553-4805-b063-eeda84049029	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	65ef34fb-8fe4-4e9d-9068-98702515ffeb	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	f291b905-a739-5e43-e053-2995a90ac40c	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	ef26e4f0-f31f-4efa-9938-28c886cf3d1d	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC	295e92a9-bcb0-4d53-ba62-e30020e9834b	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	31356804-951b-68c7-e063-6294a90a6410	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca6faa-316d-5754-e063-6394a90a7eff	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fc9b90d1-7da5-efc1-e053-6294a90a0223	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2d3f1d0b-3686-f4d7-e063-6394a90a1a76	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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