Application 204852

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

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
A204852-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05
A204852-002	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05
A204852-003	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05
A204852-004	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204852-001	AB
A204852-002	AB
A204852-003	AB
A204852-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A204852-001	TRAZODONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-002	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-003	TRAZODONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-004	TRAZODONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2020-02-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204852-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A204852-004	AB	1	`a50c72e98297…`

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	fec78f5d-2567-44d3-9f04-1a6913357019	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	34986e81-da05-46c1-8dd6-1dd7a8d1a44f	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	dfd2698d-b7a3-49e0-aa2f-1af0ca894b35	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f89ad429-0056-e4d6-e053-6294a90a7ab1	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	470a98a2-4e68-4c98-b3c8-e5eba4e55cdc	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	fdd35113-5f51-49c5-a29c-ffdddd28ef38	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	b57daea8-5a39-41c1-842e-b1d15115e36f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	24b5eee4-4210-4b90-a695-11e6a5868988	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	7baa8eef-3a5c-43b3-a5fe-0c449aacda2e	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	4370fe5c-1c40-499b-abb5-bca0a39834c6	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	a343910a-bf4c-4a41-b0ee-0e90e8355815	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Bryant Ranch Prepack	1514b3b0-7742-4247-b9fd-ea14849d3fdd	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	REMEDYREPACK INC.	b0a79ee7-3140-48cb-b734-244a4420e32c	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Aurolife Pharma LLC	295e92a9-bcb0-4d53-ba62-e30020e9834b	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852 ndc (product): 13107-079 ndc (product): 13107-080 ndc (product): 13107-082 ndc (product): 13107-081
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca6faa-316d-5754-e063-6394a90a7eff	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8fc1f03-cd9d-9fa9-e053-6294a90a8665	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204852 application number: ANDA204852

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-079	Trazodone Hydrochloride	Trazodone Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-080	Trazodone Hydrochloride	Trazodone Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-081	Trazodone Hydrochloride	Trazodone Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-082	Trazodone Hydrochloride	Trazodone Hydrochloride	Aurolife Pharma, LLC	ANDA	Current