Home Applications 206107 Application 206107
Type ANDA
Sponsor SIGMAPHARM LABS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASENAPINE MALEATE ASENAPINE MALEATE TABLET;SUBLINGUAL EQ 5MG BASE No No 002 ASENAPINE MALEATE ASENAPINE MALEATE TABLET;SUBLINGUAL EQ 10MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206107-001 ASENAPINE MALEATE ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 A206107-002 ASENAPINE MALEATE ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 74 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 2026-02-19 14:30 UTC 2026-02 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206107-001 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 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206107-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206107-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42794-016 ASENAPINE ASENAPINE Sigmapharm Laboratories, LLC ANDA Current 42794-016 ASENAPINE ASENAPINE Sigmapharm Laboratories, LLC ANDA Current 42794-017 ASENAPINE ASENAPINE Sigmapharm Laboratories, LLC ANDA Current 42794-017 ASENAPINE ASENAPINE Sigmapharm Laboratories, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 55235 ORIG 2018-08-20