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 42.

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 · 60 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	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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	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…`
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…`

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 5 · 100 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	596c3f00-1504-eaed-e063-6294a90a08bb	2026-08-19	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	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	1f74b23d-f2eb-4c18-a583-d608b7713694	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	dc1f347e-1acb-4c06-b36e-f15fecb7ac93	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	acd077db-e2b8-4d29-94c0-128439050c66	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	81a5b557-06f6-2470-e053-2991aa0a64fd	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	a31d59ed-5949-4f85-8b73-3bfd7f72d5b8	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	7bba99e5-4096-4fcb-8591-dc4a9bfe975e	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
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	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