Application 206954

Type: ANDA
Sponsor: PRINSTON INC

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
A206954-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24
A206954-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24
A206954-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24
A206954-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24
A206954-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24
A206954-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206954-001	AB
A206954-002	AB
A206954-003	AB
A206954-004	AB
A206954-005	AB
A206954-006	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 · 162 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	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-08-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 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	A206954-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206954-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206954-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206954-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206954-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206954-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206954-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206954-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206954-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUETIAPINE	QUETIAPINE	Solco Healthcare US, LLC	61b1230e-c0dc-46c6-a577-7d5dd2515eb7	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206954 application number: ANDA206954 ndc (product): 43547-518 ndc (product): 43547-519 ndc (product): 43547-520 ndc (product): 43547-523 ndc (product): 43547-522 ndc (product): 43547-521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-518	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current
43547-519	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current
43547-520	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current
43547-521	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current
43547-522	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current
43547-523	QUETIAPINE	quetiapine	Solco Healthcare US, LLC	ANDA	Current