Application 090482

Type: ANDA
Sponsor: PAR PHARM

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 50MG BASE	No	No
002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	No	No
003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	No	No
004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG BASE	No	No
005	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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090482-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09
A090482-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09
A090482-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09
A090482-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09
A090482-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09

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 1 of 6 · 215 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	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090482-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090482-002	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090482-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090482-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090482-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-05-09	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090482-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090482-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090482-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090482-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090482-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090482-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090482-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090482-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090482-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090482-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090482-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090482-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090482-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090482-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090482-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090482-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090482-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090482-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090482-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090482-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090482-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090482-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090482-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090482-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090482-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090482-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090482-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090482-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090482-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090482-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090482-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090482-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090482-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090482-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090482-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090482-005	AB	1	`5aa47cf7b7d7…`

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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine fumarate	QUETIAPINE	BluePoint Laboratories	874e50ad-5da0-4ac3-9290-79442c91399e	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	a45d8b77-f13d-41c5-8d50-15152fc6f85c	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: QUETIAPINE FUMARATE generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: QUETIAPINE FUMARATE generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bryant Ranch Prepack	45c4c3a4-3acc-413e-9746-4816d513fac6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: QUETIAPINE FUMARATE generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	XLCare Pharmaceuticals Inc.	070faf07-0ce7-4354-8643-9d222b72ecad	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	55018271-1f8f-4683-afee-8203c3bd9acc	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Direct_Rx	f6de1d2b-b10e-2e9a-e053-6394a90a735d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	42bd7dd3-9f81-4d8b-bce9-302e5559da2f	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	479c9555-5d1e-4e5c-bfde-f3812829edd8	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Preferred Pharmaceuticals, Inc.	1fe839fa-c566-4374-997f-f5b9d97b5fb8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	: Preferred Pharmaceuticals Inc.	f3c91d05-038b-40f4-8c1f-2910773ec567	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Coupler LLC	4872793c-a7be-1b65-e063-6394a90a8b3a	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	A-S Medication Solutions	aeff3ab1-24ff-417a-8bbc-2ffa413dcb87	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals,Inc.	471d8e2d-4be6-6180-e063-6394a90ac721	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE	A-S Medication Solutions	10288afa-c4dc-4897-9ec8-f4573d850779	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate
Quetiapine Fumarate	QUETIAPINE FUMARATE	AvPAK	6b7d7d2f-a50b-8e21-2de4-ccc102016384	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	NuCare Pharmaceuticals, Inc.	458cae68-c11d-e760-e063-6394a90ac04e	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Ingenus Pharmaceuticals, LLC	8923c441-c9aa-4b30-89d7-dbaaa7f66656	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	72111c36-c625-434f-9f16-7f25e0ff75f3	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: QUETIAPINE FUMARATE generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	3ffe0294-3959-2755-e054-00144ff8d46c	2025-11-14	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31475	ORIG	2017-06-21
48372	ORIG	2017-05-15