Active ingredient
Loxapine
25 finished FDA listings contain Loxapine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LOXAPINE, LOXAPINE SUCCINATE
- Dosage forms
- Aerosol, Powder, Capsule
- Routes
- Oral, Respiratory (Inhalation)
- Manufacturers / labelers
- 8
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1 · 50 mg/1
- Brand names in FDA listings
- Adasuve
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6475
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 |
|---|---|---|---|
| ANDA 072062 | WATSON LABS | 1988-06-15 | 2 |
| ANDA 072204 | WATSON LABS | 1988-06-15 | 2 |
| ANDA 072205 | WATSON LABS | 1988-06-15 | 1 |
| ANDA 072206 | WATSON LABS | 1988-06-15 | 1 |
| ANDA 076868 | ELITE LABS INC | 2005-08-04 | 5 |
| ANDA 090695 | LANNETT CO INC | 2011-09-26 | 13 |
| NDA 022549 | NOVA PNEUMA | 2012-12-21 | 1 |
Official labeling on DailyMed
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-07
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 18 · 2026-07-16
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 20 · 2026-07-15
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 16 · 2026-07-15
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 17 · 2026-07-13
- ADASUVE (LOXAPINE) AEROSOL, POWDER [ALEXZA PHARMACEUTICALS, INC.] · version 8 · 2026-07-07
- LOXAPINE CAPSULE [REMEDYREPACK INC.] · version 15 · 2026-01-12
- LOXAPINE CAPSULE [CHARTWELL RX, LLC] · version 3 · 2025-12-09
- LOXAPINE CAPSULE [ACTAVIS PHARMA, INC.] · version 20 · 2025-07-16
- LOXAPINE CAPSULE [ELITE LABORATORIES, INC.] · version 8 · 2025-03-03
- LOXAPINE CAPSULE [COUPLER LLC] · version 1 · 2025-02-03
- LOXAPINE CAPSULE [COUPLER LLC] · version 1 · 2025-02-03
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.