FDA Orange Book · active-ingredient family
Arformoterol tartrate
Arformoterol tartrate: 1 brand, 17 generics; first approved Oct 06, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
17
Listed patents
0
Presentations
18
Brand (NDA) products
Originator applications
- BROVANARLDLUPINNDA 0219122006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Discontinued —
Generic (ANDA) products (17)
Abbreviated applications
- ARFORMOTEROL TARTRATESABA ILAC SANAYIANDA 2184292025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEMICRO LABSANDA 2185552025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEAUCTAANDA 2183802025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATELEXENPHARMANDA 2181562024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEDR REDDYSANDA 2150322024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATENEOCUBES PHARMAANDA 2163032024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEAIPING PHARM INCANDA 2149012024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEWILSHIRE PHARMS INCANDA 2168152022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATERSMANKIND PHARMAANDA 2161282022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATESUN PHARMANDA 2153852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEALEMBICANDA 2147792022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATERITEDOSE CORPANDA 2147362022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATELUPINANDA 2130682022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATETEVA PHARMS USAANDA 2002932021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Discontinued — - ARFORMOTEROL TARTRATECIPLAANDA 2073062021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Rx AN - ARFORMOTEROL TARTRATEGLENMARK PHARMS LTDANDA 2131322021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML SOLUTION INHALATION Discontinued — - ARFORMOTEROL TARTRATESLATE RUN PHARMAANDA 2137622021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.015MG BASE/2ML 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
20 yr 2 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 2006–2025 across 18 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1794%
Arformoterol tartrate: 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.
