FDA Orange Book · active-ingredient family
Levalbuterol hydrochloride
Levalbuterol hydrochloride is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XOPENEX · NDA 020837
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XOPENEXRLD×4 | HIKMA | NDA 020837 | — | Jan 30, 2002 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVALBUTEROL HYDROCHLORIDE×2 | NEPHRON | ANDA 215217 | AN | May 26, 2026 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | MANKIND PHARMA | ANDA 218770 | — | Oct 21, 2024 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | SUN PHARM | ANDA 207820 | — | Nov 05, 2018 | |
| LEVALBUTEROL HYDROCHLORIDE | LUOXIN AUROVITAS | ANDA 207628 | AN | Jan 31, 2017 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | LUOXIN AUROVITAS | ANDA 207625 | AN | Dec 30, 2016 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | RITEDOSE CORP | ANDA 203653 | AN | Mar 22, 2016 | |
| LEVALBUTEROL HYDROCHLORIDE | TEVA PARENTERAL | ANDA 200875 | AN | Sep 11, 2014 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | CIPLA | ANDA 078171 | AN | Dec 13, 2013 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | TEVA PHARMS USA | ANDA 090297 | AN | Apr 26, 2013 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | PHARMOBEDIENT | ANDA 077800 | — | Mar 15, 2013 | |
| LEVALBUTEROL HYDROCHLORIDE | MYLAN SPECIALITY LP | ANDA 078309 | AN | Mar 20, 2009 | |
| LEVALBUTEROL HYDROCHLORIDE×3 | IMPAX LABS INC | ANDA 077756 | AN | Apr 09, 2008 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Levalbuterol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
