Application 076762

Type: ANDA
Sponsor: MYLAN

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 1.

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	Approval date
A076762-001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01
A076762-002	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01
A076762-003	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01
A076762-004	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`d06236e962d9…`

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	A076762-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076762-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076762-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076762-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076762-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076762-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076762-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076762-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076762-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076762-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076762-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076762-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076762-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076762-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076762-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076762-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076762-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076762-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076762-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076762-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076762-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076762-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076762-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076762-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076762-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076762-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076762-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076762-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076762-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076762-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076762-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076762-004	AB	1	`ea99ee380514…`

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
0378-7005	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7010	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7025	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7050	Loxapine	loxapine	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-3457	Loxapine	loxapine	A-S Medication Solutions	ANDA	Current
51079-901	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-901	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-902	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-902	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
51079-903	Loxapine	loxapine	Mylan Institutional Inc.	ANDA	Current
70518-0995	Loxapine	loxapine	REMEDYREPACK INC.	ANDA	Current
70518-0995	Loxapine	loxapine	REMEDYREPACK INC.	ANDA	Current