Application 204316

Type: ANDA
Sponsor: HETERO LABS LTD V

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 1.

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
A204316-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204316-001	AB
A204316-002	AB
A204316-003	AB
A204316-004	AB
A204316-005	AB
A204316-006	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 5 · 168 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	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A204316-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204316-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204316-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204316-004	AB	1	`2680178bc6a6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	3085f68d-e83c-4f59-b058-8bdae7f4e537	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b8864cb9-1c6a-4e36-9893-eb1403ee8745	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	XLCare Pharmaceuticals Inc.	070faf07-0ce7-4354-8643-9d222b72ecad	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	ST. MARY'S MEDICAL PARK PHARMACY	3624c430-2a17-a83a-e063-6394a90add93	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	Camber Pharmaceuticals, Inc.	5c6aeb85-3ac2-4448-b544-9a4c5f562ed3	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316 ndc (product): 31722-767 ndc (product): 31722-768 ndc (product): 31722-769 ndc (product): 31722-766 ndc (product): 31722-764 ndc (product): 31722-765

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
31722-764	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-764	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-765	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-765	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-766	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-766	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-767	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-767	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-768	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-768	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-769	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-769	Quetiapine Fumarate	Quetiapine Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current