Application 211146

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 5MG BASE	No	No
002	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 10MG BASE	No	No
003	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 · 72 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211146-002	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL		2021-09-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211146-003	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL		2021-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211146-001	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL		2021-09-17	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A211146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211146-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211146-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211146-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211146-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211146-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211146-003	AB	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68918	ORIG	2021-10-08