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 1.

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 · 56 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
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211116-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2024-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2024-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2024-05-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211116-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211116-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211116-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 100 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	2863317d-657b-4dc6-81fb-b7158ea03498	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	007f38e0-653b-43e4-a1c1-b59997b2762a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	68bcae4b-f4c3-4d28-af76-d182b707fc73	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	5bc5f266-6c0e-4b9a-b6e0-ea694928b948	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	American Health Packaging	f715085a-be56-497e-ad92-9fec3aba70b5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fa890-0a39-9361-e063-6294a90a1bb5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	562fdfb9-c060-63bc-e063-6294a90ad840	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	614f2c6e-0bb7-43e0-85d8-5eef8eeae208	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	04c287ca-5efa-469d-ab39-ff16d9b1e0b3	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	55f18806-6c23-783b-e063-6294a90acc46	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1ec27d5d-1a88-428e-8de2-7418a3535a18	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	6aaf08aa-9aa3-aabd-e053-2a91aa0a86d1	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	38e9820a-6edc-4bf5-b5e4-034b9e48b583	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	5605e909-dc75-4578-94c6-41bb96ba3e2a	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	0545507a-5c11-4451-872a-d2f7f0aaecd4	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
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	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	310c4b81-d2cf-4014-873d-e71d036105de	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	78c3188c-d42f-4d3d-aa42-3c146dfe08ee	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	51012256-b249-ccbb-e063-6394a90af4fa	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE