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 5 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	Coupler LLC	2c7dca0c-8313-7d85-e063-6294a90aca61	2025-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8fc1f03-cd9d-9fa9-e053-6294a90a8665	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29ac7183-e574-506e-e063-6394a90a77c9	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	be0dc037-d30a-4f07-ab7c-1695637b3740	2024-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a71063f9-cdc6-46bc-9eb4-626f288e46d9	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	9df17765-5d41-4e26-98de-850658114534	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	85bb3f78-5cf2-1319-e053-2991aa0ade75	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6adb446d-cd2f-3d6b-e053-2991aa0a2114	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	88ac1a9d-8483-4b29-9fe6-2e60e51f3005	2024-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Medsource Pharmaceuticals	138fef7b-db83-88c4-e063-6394a90ab0ac	2024-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Medsource Pharmaceuticals	12f1737b-c021-d0f2-e063-6294a90a6f29	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Asclemed USA, Inc.	04a676ee-358e-484d-9de4-a9a88d908ba8	2024-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	3df90104-ef2c-4a82-b007-9843c43969ae	2023-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	ac678c51-b1d3-4d6b-9599-7ef565b469d2	2023-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	3c8c3d2b-9108-40fa-90d9-6ed545cf6549	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	203881a3-37d0-41dd-86c5-1e53fb784326	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	a90caa68-b28e-425f-b77c-7b566ac17dc2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	f6c3fb84-5b68-4675-a853-fe49bfbf3f9f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Proficient Rx LP	2a1d0989-6ed5-4a2f-bd03-73d61eb40232	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5d22a06c-9cb8-4b49-8d67-769d181ad70c	2021-03-10	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.