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FDA Orange Book · active-ingredient family

Arformoterol tartrate

Arformoterol tartrate is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BROVANA · NDA 021912

1

Brand (NDA)

17

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
BROVANARLDLUPINNDA 021912Oct 06, 2006

Generic (ANDA) products (17)

ProductApplicantApplicationTEApproved
ARFORMOTEROL TARTRATESABA ILAC SANAYIANDA 218429ANApr 25, 2025
ARFORMOTEROL TARTRATEMICRO LABSANDA 218555ANMar 07, 2025
ARFORMOTEROL TARTRATEAUCTAANDA 218380ANFeb 03, 2025
ARFORMOTEROL TARTRATELEXENPHARMANDA 218156ANNov 18, 2024
ARFORMOTEROL TARTRATEDR REDDYSANDA 215032ANJun 03, 2024
ARFORMOTEROL TARTRATENEOCUBES PHARMAANDA 216303ANMay 17, 2024
ARFORMOTEROL TARTRATEAIPING PHARM INCANDA 214901ANApr 02, 2024
ARFORMOTEROL TARTRATEWILSHIRE PHARMS INCANDA 216815ANNov 25, 2022
ARFORMOTEROL TARTRATEMANKIND PHARMAANDA 216128ANNov 15, 2022
ARFORMOTEROL TARTRATESUN PHARMANDA 215385ANMay 26, 2022
ARFORMOTEROL TARTRATEALEMBICANDA 214779ANMay 10, 2022
ARFORMOTEROL TARTRATERITEDOSE CORPANDA 214736ANMar 02, 2022
ARFORMOTEROL TARTRATELUPINANDA 213068ANFeb 07, 2022
ARFORMOTEROL TARTRATETEVA PHARMS USAANDA 200293ANNov 09, 2021
ARFORMOTEROL TARTRATECIPLAANDA 207306ANJun 22, 2021
ARFORMOTEROL TARTRATEGLENMARK PHARMS LTDANDA 213132Jun 22, 2021
ARFORMOTEROL TARTRATESLATE RUN PHARMAANDA 213762ANJun 22, 2021

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.

Arformoterol tartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.