Application 206098

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ASENAPINE	ASENAPINE	TABLET;SUBLINGUAL	5MG	No	No
002	ASENAPINE	ASENAPINE	TABLET;SUBLINGUAL	10MG	No	No
003	ASENAPINE MALEATE	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 2.5MG 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
A206098-001	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A206098-002	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A206098-003	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206098-001	AB
A206098-002	AB
A206098-003	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 · 103 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	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206098-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206098-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206098-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206098-002	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	A206098-003	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2021-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206098-001	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 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	A206098-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206098-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206098-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206098-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206098-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206098-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206098-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206098-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206098-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206098-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206098-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206098-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206098-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206098-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206098-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206098-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206098-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206098-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206098-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206098-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206098-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206098-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206098-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206098-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206098-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206098-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206098-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206098-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206098-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206098-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206098-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206098-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206098-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206098-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206098-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206098-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206098-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206098-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206098-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206098-001	AB	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A206098-002	PC	2021-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206098-002	PC	2021-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206098-001	PC	2021-06-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206098-002	PC	2021-06-08	`5aa47cf7b7d7…`

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	Alembic Pharmaceuticals Inc.	16e1cc9f-7699-49ea-b179-acb65e162304	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206098 application number: ANDA206098 ndc (product): 62332-198 ndc (product): 62332-199 ndc (product): 62332-544
Asenapine	ASENAPINE	Alembic Pharmaceuticals Limited	cf587c48-9cd2-4dc5-b0e9-21783c5633a6	2023-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206098 application number: ANDA206098 ndc (product): 46708-544 ndc (product): 46708-199 ndc (product): 46708-198

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
46708-198	Asenapine	Asenapine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-198	Asenapine	Asenapine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-199	Asenapine	Asenapine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-199	Asenapine	Asenapine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-544	Asenapine	Asenapine	Alembic Pharmaceuticals Limited	ANDA	Current
62332-198	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-198	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-198	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-199	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-199	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-199	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-544	Asenapine	Asenapine	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49687	ORIG	2017-09-07