Application 090749

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 50MG BASE	No	No
002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 100MG BASE	No	No
003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 200MG BASE	No	No
004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 300MG BASE	No	No
005	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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090749-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27
A090749-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27
A090749-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27
A090749-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27
A090749-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090749-001	AB
A090749-002	AB
A090749-003	AB
A090749-004	AB
A090749-005	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 6 · 215 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	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-001	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-002	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-003	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-004	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-005	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2012-03-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090749-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090749-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090749-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090749-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090749-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090749-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090749-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090749-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090749-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090749-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090749-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090749-005	AB	1	`03ed91905a0d…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	Golden State Medical Supply, Inc.	6fc9c8e2-6f34-aa43-e053-2a91aa0ac377	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090749 application number: ANDA090749 ndc (product): 51407-071
Quetiapine Fumarate	QUETIAPINE FUMARATE	Hikma Pharmaceuticals USA Inc.	271e9fb7-3c70-43fc-8279-5adf189f3c22	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090749 application number: ANDA090749
Quetiapine Fumarate	QUETIAPINE FUMARATE	Aphena Pharma Solutions - Tennessee, LLC	60316ccd-c042-4ea0-9d05-3caf7cc2cab1	2021-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090749 application number: ANDA090749 ndc (product): 71610-141 ndc (product): 71610-136 ndc (product): 71610-128 ndc (product): 71610-127

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 2 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
67296-1336	Quetiapine Fumarate	Quetiapine Fumarate	RedPharm Drug, Inc.	ANDA	Current
67296-1336	Quetiapine Fumarate	Quetiapine Fumarate	RedPharm Drug, Inc.	ANDA	Current
67296-1336	Quetiapine Fumarate	Quetiapine Fumarate	RedPharm Drug, Inc.	ANDA	Current
69189-0495	Quetiapine Fumarate	Quetiapine Fumarate	Avera McKennan Hospital	ANDA	Current
71610-127	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-127	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-128	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-128	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-136	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-136	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-141	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-141	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9291	ORIG	2012-03-29