Application 203359

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 50MG BASE	No	No
003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 100MG BASE	No	No
004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 200MG BASE	No	No
005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 300MG BASE	No	No
006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203359-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17
A203359-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A203359-001	AB
A203359-002	AB
A203359-003	AB
A203359-004	AB
A203359-005	AB
A203359-006	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 7 · 258 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
2026-09-14 22:38:34	2026-08	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2016-05-17	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203359-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203359-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203359-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203359-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203359-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203359-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203359-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203359-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203359-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203359-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203359-004	AB	1	`b8a1b40f171c…`

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 · 2 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	293a9857-d138-4583-abc9-35b75660e324	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203359 application number: ANDA203359 ndc (product): 71335-1362
Quetiapine fumarate	QUETIAPINE FUMARATE	Macleods Pharmaceuticals Limited	531cbe20-dff2-4983-9788-4543079f83ff	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203359 application number: ANDA203359 ndc (product): 33342-105 ndc (product): 33342-101 ndc (product): 33342-099 ndc (product): 33342-104 ndc (product): 33342-103 ndc (product): 33342-100

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 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-099	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-099	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-099	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-099	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-099	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-100	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-100	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-100	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-100	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-100	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-101	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-101	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-101	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-101	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-101	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-103	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-103	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-103	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-103	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-103	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-104	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-104	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-104	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-104	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-104	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-105	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-105	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-105	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-105	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-105	Quetiapine fumarate	Quetiapine fumarate	Macleods Pharmaceuticals Limited	ANDA	Current
68788-7195	Quetiapine fumarate	Quetiapine fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7195	Quetiapine fumarate	Quetiapine fumarate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1909	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-1909	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-1909	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2547	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2547	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2547	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2547	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2672	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2672	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2672	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2672	Quetiapine fumarate	Quetiapine fumarate	REMEDYREPACK INC.	ANDA	Current
71335-1362	Quetiapine fumarate	Quetiapine fumarate	Bryant Ranch Prepack	ANDA	Current
71335-1362	Quetiapine fumarate	Quetiapine fumarate	Bryant Ranch Prepack	ANDA	Current
71335-1362	Quetiapine fumarate	Quetiapine fumarate	Bryant Ranch Prepack	ANDA	Current