FDA Orange Book · active-ingredient family
Levalbuterol hydrochloride
Levalbuterol hydrochloride: 1 brand, 12 generics; first approved Mar 25, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
33
Brand (NDA) products
Originator applications
- XOPENEXRLDHIKMANDA 02083720024 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — EQ 0.0103% BASE SOLUTION INHALATION Discontinued — EQ 0.25% BASE SOLUTION INHALATION Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- LEVALBUTEROL HYDROCHLORIDENEPHRONANDA 21521720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDEMANKIND PHARMAANDA 21877020243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Discontinued — EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — - LEVALBUTEROL HYDROCHLORIDESUN PHARMANDA 20782020183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Discontinued — EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — - LEVALBUTEROL HYDROCHLORIDELUOXIN AUROVITASANDA 2076282017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDELUOXIN AUROVITASANDA 20762520163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Rx AN EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDERITEDOSE CORPANDA 20365320163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Rx AN EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDETEVA PARENTERALANDA 2008752014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDECIPLAANDA 07817120133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Rx AN EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDERSTEVA PHARMS USAANDA 09029720133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Rx AN EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDEPHARMOBEDIENTANDA 07780020133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.0103% BASE SOLUTION INHALATION Discontinued — EQ 0.021% BASE SOLUTION INHALATION Discontinued — EQ 0.042% BASE SOLUTION INHALATION Discontinued — - LEVALBUTEROL HYDROCHLORIDERSMYLAN SPECIALITY LPANDA 0783092009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25% BASE SOLUTION INHALATION Rx AN - LEVALBUTEROL HYDROCHLORIDEIMPAX LABS INCANDA 07775620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.021% BASE SOLUTION INHALATION Rx AN EQ 0.042% BASE SOLUTION INHALATION Rx AN EQ 0.0103% BASE SOLUTION INHALATION Rx AN
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
27 yr 11 mo ago
Most recent approval
5 mo ago
Approvals span 1999–2026 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Levalbuterol hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
