Application 208228

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
003	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208228-001	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07
A208228-002	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07
A208228-003	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208228-001	AB
A208228-002	AB
A208228-003	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 · 69 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	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-002	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-003	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208228-001	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-07-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A208228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208228-001	AB	1	`301d65b070ca…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
vilazodone hydrochloride	VILAZODONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	061efdcc-40ea-4647-8cc8-01cd1ccca68b	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208228 application number: ANDA208228
vilazodone hydrochloride	VILAZODONE HYDROCHLORIDE	Northstar Rx LLC	701c8b84-13ae-4adb-af7a-304bf1f21e3b	2024-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208228 application number: ANDA208228
vilazodone hydrochloride	VILAZODONE HYDROCHLORIDE	Proficient Rx LP	f68720fd-9122-4922-b472-733da8bd0a00	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208228 application number: ANDA208228
vilazodone hydrochloride	VILAZODONE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	c3e167cd-7f56-45eb-80df-a60fa1392e57	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208228 application number: ANDA208228

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.