Application 205960

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ASENAPINE MALEATE	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 2.5MG BASE	No	No
002	ASENAPINE MALEATE	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 10MG BASE	No	No
003	ASENAPINE MALEATE	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 5MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205960-001	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A205960-002	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A205960-003	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205960-001	AB
A205960-002	AB
A205960-003	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 3 · 104 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	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 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	A205960-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205960-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205960-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205960-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e	2024-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205960 application number: ANDA205960 ndc (product): 51991-358 ndc (product): 51991-359 ndc (product): 51991-360 ndc (product): 51991-928 ndc (product): 51991-361
Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	4c7a1b17-e73e-4417-a172-bfb03569d7ff	2021-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205960 application number: ANDA205960 ndc (product): 69539-057 ndc (product): 69539-245 ndc (product): 69539-060 ndc (product): 69539-059 ndc (product): 69539-058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-358	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-358	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-359	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-359	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-360	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-360	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-360	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-360	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-361	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-361	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-361	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-361	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-928	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-928	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-928	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-928	Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
64330-625	Asenapine Maleate	Asenapine Maleate	Centaur Pharmaceuticals Private Limited	ANDA	Current
69539-057	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-057	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-058	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-059	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-059	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-059	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-060	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-245	Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65852	ORIG	2021-01-07