Application 200363

Type: ANDA
Sponsor: TORRENT 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	Approval date
A200363-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27
A200363-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27
A200363-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27
A200363-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27
A200363-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27
A200363-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200363-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200363-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200363-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200363-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200363-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	2012-03-27	`b8a1b40f171c…`

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	A200363-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200363-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200363-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200363-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200363-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200363-006	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A200363-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200363-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200363-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200363-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200363-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200363-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200363-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200363-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200363-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200363-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200363-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200363-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200363-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200363-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200363-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200363-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200363-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200363-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200363-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200363-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200363-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200363-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200363-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200363-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200363-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200363-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200363-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200363-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200363-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200363-006	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 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-148	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-148	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-149	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-149	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-150	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-150	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-151	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-151	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-152	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-152	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-153	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current
13668-153	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TORRENT PHARMACEUTICALS LIMITED	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9819	ORIG	2012-03-30