Application 090681

Type: ANDA
Sponsor: ACCORD HLTHCARE

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 150MG BASE	No	No
002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	No	No
003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG BASE	No	No
004	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090681-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09
A090681-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090681-001	AB
A090681-002	AB
A090681-003	AB
A090681-004	AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090681-001	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-002	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-003	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-004	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-11-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090681-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090681-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090681-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090681-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090681-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090681-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090681-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090681-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090681-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090681-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090681-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090681-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090681-004	AB	1	`d06236e962d9…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	3ffe0294-3959-2755-e054-00144ff8d46c	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681 ndc (product): 16729-095 ndc (product): 16729-097 ndc (product): 16729-109 ndc (product): 16729-096
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd11db2d-364d-9bd6-e053-6394a90ade0b	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd17163f-a308-5c9a-e053-6294a90a2ae6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681
Quetiapine Fumarate ER	QUETIAPINE FUMARATE ER	Direct_Rx	fd12e3cb-8b9b-4ea0-e053-6294a90a4e7a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090681 application number: ANDA090681

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-095	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-095	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-095	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-095	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-096	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-096	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-096	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-096	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-097	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-097	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-097	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-097	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-109	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-109	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-109	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
16729-109	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Accord Healthcare Inc.	ANDA	Current
50090-3198	QUETIAPINE FUMARATE	quetiapine fumarate	A-S Medication Solutions	ANDA	Current
50090-3198	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	A-S Medication Solutions	ANDA	Current
50090-5442	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	A-S Medication Solutions	ANDA	Current
68001-512	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-512	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-513	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-513	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-514	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-514	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-515	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
68001-515	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	Bluepoint Laboratories	ANDA	Current
70518-1841	QUETIAPINE FUMARATE	quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-1841	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current
70518-1841	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current
70518-1841	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current
70518-1841	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current
70518-1985	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current
70518-2238	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48373	ORIG	2017-05-15
48362	ORIG	2017-05-12
45926	ORIG	2016-11-08
45795	ORIG	2016-11-02