Application 211405

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 400MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211405-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL			2018-10-26

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`cb3db0bc1861…`

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 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	c6c454c4-3eae-48ae-bf17-5dccdb659141	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	d38f0f4e-dc0f-4c92-a212-c4da3db74801	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	3085f68d-e83c-4f59-b058-8bdae7f4e537	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b8864cb9-1c6a-4e36-9893-eb1403ee8745	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ea9b9ed1-4be0-4dc0-b1dd-239caff5253e	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	02b19885-2987-4c46-8d2a-5e59656f72e8	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	695415b1-083d-4540-9f41-bde4b201f834	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	c52a9bff-8a03-44f5-9128-799c7dca0467	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	94a81681-381e-4b3b-89ac-e86dcbe7f890	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	fd9cce28-0052-4b0b-8a66-a1615e082d95	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE	Coupler LLC	5643d339-50ea-405d-e063-6394a90a3b70	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine Fumarate	QUETIAPINE FUMARATE	NorthStar Rx LLC	e6e25ef9-2671-489e-8eca-58bedb4f59ab	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	55f358e1-9458-b197-e063-6394a90a3f0e	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE FUMARATE	Unit Dose Solutions, Inc.	55f574bc-ec55-93e2-e063-6394a90a1d47	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	559fdce5-ab3e-0d02-e063-6394a90a7fbd	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE	Unit Dose Solutions, Inc.	55a5671b-7771-0adf-e063-6294a90acfa6	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE FUMARATE	St. Mary's Medical Park Pharmacy	36248b77-277c-7d66-e063-6394a90ae1e8	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE	Coupler LLC	544f6e91-e61f-c57a-e063-6294a90af9d1	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE FUMARATE	St. Mary's Medical Park Pharmacy	3624100f-6e3f-a2ad-e063-6294a90a0fc0	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current
65162-431	Quetiapine	Quetiapine Extended-release	Amneal Pharmaceuticals LLC	ANDA	Current