Home Applications 206098 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 45 .
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 RLD / RS 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.
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 · 115 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-11-14 07:37:17 2026-10 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 observed states.
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ASENAPINE ASENAPINE Sigmapharm Laboratories, LLC 3512687b-d1c7-45c4-8822-3a2ad53575a5 2025-11-25 Boxed warning, Warnings, Adverse reactions Name fallback brand name: ASENAPINE generic name: ASENAPINE SECUADO ASENAPINE Noven Therapeutics, LLC 685eaf44-5944-4f38-afba-0a4fc0b3462b 2025-01-30 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ASENAPINE Asenapine ASENAPINE MALEATE MSN LABORATORIES PRIVATE LIMITED 4c7a1b17-e73e-4417-a172-bfb03569d7ff 2021-08-26 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Asenapine
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 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