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FDA Orange Book · active-ingredient family

Bitolterol mesylate

Bitolterol mesylate: 2 brands, 0 generics; first approved Dec 28, 1984.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Originator applications

Brand (NDA) products

TORNALATE
NDA 0195481992
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.2%SOLUTIONINHALATIONDiscontinued—
TORNALATE
NDA 0187701984
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.37MG/INHAEROSOL, METEREDINHALATIONDiscontinued—
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Dec 28, 1984
42 yr 2 mo ago
Most recent approval
Feb 19, 1992
34 yr 11 mo ago

Approvals span 1984–1992 across 2 FDA applications.

Brand (NDA) 2100%
Generic (ANDA) 00%

Bitolterol mesylate — 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.

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