Application 090695

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 5MG BASE	No	No
002	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 10MG BASE	No	No
003	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 25MG BASE	No	No
004	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090695-001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-002	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-003	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-004	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090695-001	AB
A090695-002	AB
A090695-003	AB
A090695-004	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
2026-08-18 06:07:40	2026-07	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`

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
2026-08-18 06:07:40	2026-07	A090695-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090695-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-004	AB	1	`d8e5a09893c0…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loxapine	LOXAPINE	REMEDYREPACK INC.	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695 ndc (product): 70518-1896
Loxapine	LOXAPINE	REMEDYREPACK INC.	2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695 ndc (product): 70518-1792
Loxapine	LOXAPINE	REMEDYREPACK INC.	74ac619f-216b-4a79-b23a-158f4e44d25d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695 ndc (product): 70518-1681
Loxapine	LOXAPINE	Chartwell RX, LLC	3e412c36-66b0-444b-833b-cea79976844e	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2cf85ba7-7b62-6519-e063-6394a90a32c4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2ce01a5d-b9bc-af4d-e063-6394a90af9e4	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Lannett Company, Inc.	509bad3c-b563-4042-b270-d28bde19f224	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695 ndc (product): 0527-1395 ndc (product): 0527-1394 ndc (product): 0527-1396 ndc (product): 0527-1397
Loxapine	LOXAPINE	Proficient Rx LP	3fa7b9c3-f500-49d5-b0c5-27ff01779713	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1394	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1394	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1394	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1394	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1394	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1395	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1395	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1395	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1395	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1395	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1396	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1396	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1396	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1396	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1396	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1397	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1397	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1397	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1397	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
0527-1397	Loxapine	Loxapine	Lannett Company, Inc.	ANDA	Current
10135-585	Loxapine	Loxapine succinate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-586	Loxapine	Loxapine succinate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-587	Loxapine	Loxapine succinate	Marlex Pharmaceuticals Inc	ANDA	Current
10135-588	Loxapine	Loxapine succinate	Marlex Pharmaceuticals Inc	ANDA	Current
17856-1397	Loxapine	Loxapine	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-4701	Loxapine	Loxapine	A-S Medication Solutions	ANDA	Current
50090-4701	Loxapine	Loxapine	A-S Medication Solutions	ANDA	Current
50090-4701	Loxapine	Loxapine	A-S Medication Solutions	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1681	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1792	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1792	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-1896	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-2120	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-2120	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-2120	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current
70518-2120	Loxapine	Loxapine	REMEDYREPACK INC.	ANDA	Current