Active ingredient
Asenapine
24 finished FDA listings contain Asenapine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ASENAPINE, ASENAPINE MALEATE
- Dosage forms
- Film, Extended Release, Tablet
- Routes
- Sublingual, Transdermal
- Manufacturers / labelers
- 7
- Strengths listed
- 10 mg/1 · 2.5 mg/1 · 3.8 mg/d · 5 mg/1 · 5.7 mg/d · 7.6 mg/d
- Brand names in FDA listings
- Asenapine, Saphris, Secuado
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 784649
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022117 | ABBVIE | 2009-08-13 | 3 |
| NDA 212268 | HISAMITSU | 2019-10-11 | 3 |
| ANDA 205960 | BRECKENRIDGE | 2020-12-10 | 10 |
| ANDA 206098 | ALEMBIC | 2020-12-10 | 6 |
| ANDA 206107 | SIGMAPHARM LABS LLC | 2020-12-10 | 2 |
Official labeling on DailyMed
- SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.] · version 22 · 2025-12-12
- ASENAPINE TABLET [SIGMAPHARM LABORATORIES, LLC] · version 11 · 2025-11-26
- ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS INC.] · version 16 · 2025-04-28
- SECUADO (ASENAPINE) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC] · version 13 · 2025-02-03
- ASENAPINE (ASENAPINE MALEATE) TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 5 · 2024-03-27
- ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] · version 3 · 2023-01-23
- ASENAPINE (ASENAPINE MALEATE) TABLET [MSN LABORATORIES PRIVATE LIMITED] · version 7 · 2021-09-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.