FDA — authorised 15 September 1978
- Application: ANDA085889
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
🇺🇸 ISOETHARINE HYDROCHLORIDE in United States
FDA authorised ISOETHARINE HYDROCHLORIDE on 15 September 1978
Marketing authorisations
FDA — authorised 15 September 1978
- Application: ANDA085997
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 23 October 1979
- Application: ANDA086899
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 February 1980
- Application: ANDA087025
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 30 March 1981
- Application: ANDA086711
- Marketing authorisation holder: NEPHRON
- Local brand name: BETA-2
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 8 April 1981
- Application: ANDA087324
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 8 April 1981
- Application: ANDA087396
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 3 June 1983
- Application: ANDA088275
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 29 July 1983
- Application: ANDA088144
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 16 September 1983
- Application: ANDA088226
- Marketing authorisation holder: ROXANE
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 June 1991
- Application: ANDA089615
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 June 1991
- Application: ANDA089616
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 June 1991
- Application: ANDA089618
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 June 1991
- Application: ANDA089614
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 June 1991
- Application: ANDA089617
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA089819
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE S/F
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA089820
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE S/F
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA086763
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA088470
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088471
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA088472
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA087101
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA089817
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE S/F
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA087937
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA087938
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA087389
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA089252
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE S/F
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA086651
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA087390
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA089818
- Marketing authorisation holder: DEY
- Local brand name: ISOETHARINE HYDROCHLORIDE S/F
- Indication: SOLUTION — INHALATION
- Status: approved
ISOETHARINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ISOETHARINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 15 September 1978; FDA authorised it on 15 September 1978; FDA authorised it on 23 October 1979.
Who is the marketing authorisation holder for ISOETHARINE HYDROCHLORIDE in United States?
PARKE DAVIS holds the US marketing authorisation.