Is there a generic for Isoetharine hydrochloride?

Yes. The FDA Orange Book lists 34 approved generic (ANDA) applications for Isoetharine hydrochloride, referencing the brand BRONKOSOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Isoetharine hydrochloride?

BRONKOSOL (NDA 012339, SANOFI AVENTIS US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Isoetharine hydrochloride are approved?

Isoetharine hydrochloride is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Isoetharine hydrochloride

Isoetharine hydrochloride: 1 brand, 34 generics; first approved Nov 15, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 34 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

BRONKOSOL
SANOFI AVENTIS USNDA 012339—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —
0.25% SOLUTION INHALATION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—
0.25%	SOLUTION	INHALATION	Discontinued	—

Generic (ANDA) products (34)

Abbreviated applications

ISOETHARINE HYDROCHLORIDE
ASTRAZENECAANDA 0896141991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.062% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ASTRAZENECAANDA 0896151991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ASTRAZENECAANDA 0896161991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.167% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ASTRAZENECAANDA 0896171991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ASTRAZENECAANDA 0896181991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE S/F
DEYANDA 0898171988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.08% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE S/F
DEYANDA 0898181988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE S/F
DEYANDA 0898191988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.17% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE S/F
DEYANDA 0898201988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE S/F
DEYANDA 0892521986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0881451984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.14% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
ASTRAZENECAANDA 0884701984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.167% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
ASTRAZENECAANDA 0884711984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
ASTRAZENECAANDA 0884721984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 0882261983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.167% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0881461983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
BAXTER HLTHCAREANDA 0881441983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.08% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 0882751983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
DEYANDA 0881871982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.08% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
DEYANDA 0881881982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.25% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
ASTRAZENECAANDA 0879371982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.062% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
ASTRAZENECAANDA 0879381982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125% SOLUTION INHALATION Discontinued —
BETA-2
NEPHRONANDA 086711—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ALPHARMA US PHARMSANDA 087101—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
DEYANDA 087389—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
DEYANDA 087390—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.17% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDERLD
DEYANDA 086763—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.062%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.167%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.08%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.17%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.14%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.167%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.167%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.08%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.08%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.062%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.17%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

ISOETHARINE HYDROCHLORIDE

INTL MEDICATIONANDA 086651—8 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.077%	SOLUTION	INHALATION	Discontinued	—
0.08%	SOLUTION	INHALATION	Discontinued	—
0.1%	SOLUTION	INHALATION	Discontinued	—
0.143%	SOLUTION	INHALATION	Discontinued	—
0.167%	SOLUTION	INHALATION	Discontinued	—
0.2%	SOLUTION	INHALATION	Discontinued	—
0.25%	SOLUTION	INHALATION	Discontinued	—
1%	SOLUTION	INHALATION	Discontinued	—

ISOETHARINE HYDROCHLORIDE
PARKE DAVISANDA 085997—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
PARKE DAVISANDA 085889—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 087396—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 087025—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 087324—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION INHALATION Discontinued —
ISOETHARINE HYDROCHLORIDE
ROXANEANDA 086899—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION INHALATION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION	INHALATION	Discontinued	—

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

Nov 15, 1982

44 yr 6 mo ago

Most recent approval

Jun 13, 1991

35 yr 10 mo ago

Approvals span 1982–1991 across 35 FDA applications.

Brand (NDA) 13%

Generic (ANDA) 3497%

Isoetharine 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

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

Book a Demo