Application 203390

Type: ANDA
Sponsor: ALEMBIC 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 44.

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	Approval date
A203390-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28
A203390-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28
A203390-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28
A203390-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28
A203390-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28
A203390-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28

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 2 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203390-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203390-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203390-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203390-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2014-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203390-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2014-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203390-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2014-10-28	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203390-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203390-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203390-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203390-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203390-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203390-006	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A203390-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203390-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203390-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203390-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203390-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203390-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203390-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203390-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203390-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203390-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203390-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203390-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203390-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203390-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203390-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203390-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203390-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203390-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203390-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203390-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203390-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203390-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203390-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203390-006	AB	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Alembic Pharmaceuticals Limited	93ab6237-321e-4a2c-b0ca-3fc9acb31f9a	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203390 application number: ANDA203390 ndc (product): 46708-139 ndc (product): 46708-137 ndc (product): 46708-135 ndc (product): 46708-134 ndc (product): 46708-138 ndc (product): 46708-136

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-134	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-134	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-135	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-135	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-136	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-136	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-137	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-137	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-138	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-138	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-139	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-139	Quetiapine Fumarate	quetiapine fumarate	Alembic Pharmaceuticals Limited	ANDA	Current