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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211405-001	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2018-10-26	`caaa826d4ba7…`
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…`

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 5 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	Bryant Ranch Prepack	35f6ad40-192a-4d1f-ace0-9fb69b9d984d	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	385f7c3d-3299-4b04-947e-de2ee78c8241	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct Rx	db48ec02-1119-f343-e053-2a95a90afb3b	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	face6c19-3dd9-b188-e053-6294a90a62d0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	fceb9f47-8da7-7138-e053-6294a90a5558	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals Inc.	8acc0ed3-6e4f-4799-8252-5a163938fddc	2025-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Advanced Rx Pharmacy of Tennessee, LLC	d323b6c0-55fa-6caa-e053-2a95a90a3cff	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Advanced Rx Pharmacy of Tennessee, LLC	d2a76aed-a0b8-33f0-e053-2a95a90add0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	132a2483-7e49-4b0c-9db4-e6e578697fd9	2024-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	d779f317-683b-4ec6-a309-1dd54332563f	2024-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Advanced Rx of Tennessee, LLC	1cfc847b-0d8d-fc94-e063-6394a90a311f	2024-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	293a9857-d138-4583-abc9-35b75660e324	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Camber Pharmaceuticals, Inc.	5c6aeb85-3ac2-4448-b544-9a4c5f562ed3	2024-04-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	845159aa-1ac2-41b7-ac21-d4b03e43203b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	392dd5cf-4777-4985-b62b-7370134dee26	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	0fdbe32f-d04a-5666-e063-6294a90a8e36	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	ccacb909-8ee5-4223-bfee-9cfeae470ecf	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	2b387188-c2c1-4865-984c-341a358d1c6c	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	85f973e0-93e6-4856-9266-62136acb2532	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	95156201-ed16-4806-98a7-d42acc902126	2023-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE

Reported adverse events (FAERS/openFDA)#

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

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