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 2 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	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
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef6	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Lupin Pharmaceuticals, Inc.	a951cd63-d329-47c9-965a-582fa73a07c6	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Sun Pharmaceutical Industries, Inc.	ffe52b98-9872-48c1-90fd-8fcd37c3432f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE	Coupler LLC	533154bb-a596-c88b-e063-6294a90a8956	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE	Coupler LLC	52ba669d-c846-03c2-e063-6394a90ac0f0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine fumarate	QUETIAPINE	American Health Packaging	9f927ae2-a0ae-4953-99ba-8de59ee5bfca	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	58541ffd-58c3-49aa-ad90-7e91a3c0b7d6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	d3dcfb51-e67d-44dc-9186-4729f6414bf1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Coupler LLC	5074c897-bcf9-7497-e063-6394a90aa733	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	aa0d27fd-569a-4573-b45d-2de5f5a30294	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b84e1614-b077-4ea5-8d11-df68f2b926de	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	897184b1-de3c-4d59-91be-3069325fd5b2	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	da5c118f-404c-4453-aa10-a8656b1d7501	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	911bf26c-a89a-4ce1-8ff5-cfda03d0a482	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Bryant Ranch Prepack	f0ad842c-a0c2-4855-a55b-353b5338980f	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	41dbd5a5-4ae2-4ac1-8135-0fdac5c170b5	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	16f48034-b8c9-ab2b-e063-6294a90adf65	2026-04-07	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