Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sigmapharm Laboratories, LLC | Bensalem, PA, United States | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 12 inspections |
Recalls
- Apr 19, 2021 · Class III · SigmaPharm Laboratories LLC
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Lots: Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022 - Apr 19, 2021 · Class III · SigmaPharm Laboratories LLC
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Lots: Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Asenapine: every company that makes it
- Form
- tablet, sublingual
- Strength
- 10 mg
- Approval
- ANDA ANDA206107
- On the market since
- Dec 14, 2020
- Package NDCs
42794-017-0842794-017-1042794-017-22- Official label
- DailyMed (National Library of Medicine), updated Nov 25, 2025
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