FDA Orange Book · active-ingredient family
Isoproterenol hydrochloride
Isoproterenol hydrochloride: 8 brands, 29 generics; first approved Jan 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 29 ANDA applications approved.
Brands (NDA)
8
Generics (ANDA)
29
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- ISUPRELRLDBAUSCHNDA 010515—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDE3MNDA 010375—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12MG/INH AEROSOL, METERED INHALATION Discontinued — - SANOFI AVENTIS USNDA 011178—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.103MG/INH AEROSOL, METERED INHALATION Discontinued — - ABBOTTNDA 016814—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% DISC INHALATION Discontinued — - LILLYNDA 007245—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION INHALATION Discontinued — - SANOFI AVENTIS USNDA 006327—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION INHALATION Discontinued — 1% SOLUTION INHALATION Discontinued — - FISONSNDA 016813—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION INHALATION Discontinued — - SANOFI AVENTIS USNDA 006328—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET RECTAL, SUBLINGUAL Discontinued — 15MG TABLET RECTAL, SUBLINGUAL Discontinued —
Generic (ANDA) products (29)
Abbreviated applications
- ISOPROTERENOL HYDROCHLORIDEASPIROANDA 2202992026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEDEVA HOLDING ASANDA 2133052025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEGLANDANDA 2176482024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDESOMERSET THERAPS LLCANDA 2115902024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEHIKMAANDA 2117032023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEZYDUS PHARMSANDA 2155572023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEAM REGENTANDA 2147752022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEPENN LIFEANDA 2155422022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEPHARMOBEDIENTANDA 2125732022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEAVET LIFESCIENCESANDA 2121892021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEJ MOLNERANDA 2112372021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEMICRO LABSANDA 2108452021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEEUGIA PHARMAANDA 2118642021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDECIPLAANDA 2117382019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEAMNEALANDA 2105762018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEAMPHASTAR PHARMS INCANDA 2101062018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDECIPLAANDA 2103222018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDERSNEXUSANDA 2069612017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ISOPROTERENOL HYDROCHLORIDEARMOUR PHARMANDA 0879351982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.031% SOLUTION INHALATION Discontinued — - ISOPROTERENOL HYDROCHLORIDEARMOUR PHARMANDA 0879361982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.062% SOLUTION INHALATION Discontinued — - ISOPROTERENOL HYDROCHLORIDEDEYANDA 0867641982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION INHALATION Discontinued — - ISOPROTERENOL HYDROCHLORIDEALPHARMA US PHARMSANDA 085904—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12MG/INH AEROSOL, METERED INHALATION Discontinued — - ISOPROTERENOL HYDROCHLORIDEABRAXIS PHARMANDA 083431—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEBAXTER HLTHCAREANDA 083486—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEHOSPIRAANDA 083283—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEHOSPIRAANDA 083346—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEINTL MEDICATIONANDA 083724—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - ISOPROTERENOL HYDROCHLORIDEPARKE DAVISANDA 085994—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25% SOLUTION INHALATION Discontinued — - ISOPROTERENOL HYDROCHLORIDEPARKE DAVISANDA 085540—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% 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
45 yr 5 mo ago
Most recent approval
5 mo ago
Approvals span 1982–2026 across 37 FDA applications.
Brand (NDA) 822%
Generic (ANDA) 2978%
Isoproterenol 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.
