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 44.

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076762-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	2004-11-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076762-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	2004-11-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076762-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	2004-11-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076762-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	2004-11-01	`3a93d1ddd44b…`

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…`

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 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