Application 213984

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 1.5MG BASE	No	No
002	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 3MG BASE	No	No
003	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 4.5MG BASE	No	No
004	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 6MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A213984-001	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09
A213984-002	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09
A213984-003	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09
A213984-004	CARIPRAZINE HYDROCHLORIDE	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09

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 2 of 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213984-001	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	2022-09-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213984-002	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	2022-09-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213984-003	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	2022-09-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213984-004	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	2022-09-09	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213984-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213984-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213984-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213984-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213984-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213984-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213984-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213984-004	AB	1	`f41ea6bd6efb…`

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
69856	ORIG	2022-01-12