Application 203150

Type: ANDA
Sponsor: JUBILANT GENERICS

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

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
A203150-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL			2013-11-26

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2013-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203150-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL		2013-11-26	`f41ea6bd6efb…`

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	A203150-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203150-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203150-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203150-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203150-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203150-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203150-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203150-001	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 6 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	Proficient Rx LP	c1f2ccba-62f3-44e7-b06f-dea61eac9e93	2023-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Macleods Pharmaceuticals Limited	531cbe20-dff2-4983-9788-4543079f83ff	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Alembic Pharmaceuticals Limited	93ab6237-321e-4a2c-b0ca-3fc9acb31f9a	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	1a147d6c-8af8-4379-8a13-1864a9a79b84	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Aphena Pharma Solutions - Tennessee, LLC	60316ccd-c042-4ea0-9d05-3caf7cc2cab1	2021-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Quetiapine Fumarate generic name: QUETIAPINE FUMARATE
Quetiapine Fumarate	QUETIAPINE FUMARATE	Proficient Rx LP	03517f29-f270-4350-a57a-fbe1967b0096	2019-10-01	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-348	Quetiapine fumarate	Quetiapine fumarate	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-348	Quetiapine fumarate	Quetiapine fumarate	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-348	Quetiapine fumarate	Quetiapine fumarate	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current