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 2 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	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	REMEDYREPACK INC.	fec78f5d-2567-44d3-9f04-1a6913357019	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	51e1ef06-d2c8-46db-a2b4-f20d4cc1abf3	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	A-S Medication Solutions	297cdf27-5b6e-4665-93f9-8fc6aef483a0	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	34986e81-da05-46c1-8dd6-1dd7a8d1a44f	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Apotex Corp	71961ab1-951d-1493-f76c-2ff25cca2a85	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRAZODONE HYDROCHLORIDE generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	AvKARE	b3723265-7455-c25c-e053-2a95a90a379b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Coupler LLC	4c4ca53e-9201-298c-e063-6294a90a72c6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	1510cf89-a2ec-4ed5-80cb-bae84f9ec0a7	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b617348c-cb19-45df-b313-4ea6af6f1dda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trazodone Hydrochloride generic name: TRAZODONE HYDROCHLORIDE
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Zydus Lifesciences Limited	43d4be17-5fae-4326-a5c4-9e25e2db6a43	2026-01-23		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.