FDA — authorised 4 May 1988
- Application: NDA019489
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: VENTOLIN ROTACAPS
- Indication: CAPSULE — INHALATION
- Status: approved
🇺🇸 ALBUTEROL SULFATE in United States
FDA authorised ALBUTEROL SULFATE on 4 May 1988 · 76,311 US adverse-event reports
Marketing authorisations
FDA — authorised 1 February 1989
- Application: ANDA072637
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1989
- Application: ANDA072151
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1989
- Application: ANDA072152
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 1989
- Application: ANDA072620
- Marketing authorisation holder: TEVA
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1989
- Application: ANDA072860
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 1991
- Application: ANDA072894
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1991
- Application: ANDA072629
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1991
- Application: ANDA072630
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1991
- Application: ANDA072764
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1991
- Application: ANDA072765
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 February 1992
- Application: ANDA072652
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 30 March 1992
- Application: ANDA073419
- Marketing authorisation holder: TEVA
- Local brand name: ALBUTEROL SULFATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 25 June 1993
- Application: ANDA072779
- Marketing authorisation holder: TEVA
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1993
- Application: ANDA072780
- Marketing authorisation holder: TEVA
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1994
- Application: ANDA074302
- Marketing authorisation holder: MOVA
- Local brand name: ALBUTEROL SULFATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 September 1995
- Application: ANDA073533
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 17 September 1997
- Application: ANDA074880
- Marketing authorisation holder: NEPHRON
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 15 January 1998
- Application: ANDA074543
- Marketing authorisation holder: SENTISS
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 30 March 1999
- Application: ANDA075262
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ALBUTEROL SULFATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 30 September 2002
- Application: ANDA076130
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: VOSPIRE ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 June 2004
- Application: ANDA076355
- Marketing authorisation holder: NEPHRON
- Status: supplemented
FDA — authorised 21 December 2006
- Application: ANDA076867
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 26 June 2007
- Application: ANDA077788
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 25 September 2007
- Application: ANDA077772
- Marketing authorisation holder: WATSON LABS
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA076749
- Marketing authorisation holder: NEPHRON
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA077063
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 31 December 2007
- Application: ANDA077117
- Marketing authorisation holder: APOTEX INC
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 16 December 2008
- Application: ANDA077839
- Marketing authorisation holder: RITEDOSE CORP
- Status: approved
FDA — authorised 5 April 2010
- Application: ANDA078623
- Marketing authorisation holder: APOTEX INC
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 12 May 2010
- Application: ANDA079241
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ALBUTEROL SULFATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 7 October 2011
- Application: NDA021747
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: COMBIVENT RESPIMAT
- Indication: SPRAY, METERED — INHALATION
- Status: approved
FDA — authorised 1 October 2012
- Application: ANDA202496
- Marketing authorisation holder: RITEDOSE CORP
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA207857
- Marketing authorisation holder: SUN PHARM
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA207875
- Marketing authorisation holder: SUN PHARM
- Local brand name: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 17 October 2017
- Application: ANDA206224
- Marketing authorisation holder: LUOXIN AUROVITAS
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA207046
- Marketing authorisation holder: RISING
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211397
- Marketing authorisation holder: ACERTIS PHARMS
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA212197
- Marketing authorisation holder: QUAGEN
- Local brand name: ALBUTEROL SULFATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA203760
- Marketing authorisation holder: PADAGIS US
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA209959
- Marketing authorisation holder: CIPLA
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 20 April 2020
- Application: ANDA211888
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: supplemented
FDA — authorised 14 May 2020
- Application: ANDA213657
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2020
- Application: ANDA206532
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: approved
FDA — authorised 24 August 2020
- Application: ANDA209954
- Marketing authorisation holder: LUPIN
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 8 October 2020
- Application: ANDA213524
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2021
- Application: ANDA207085
- Marketing authorisation holder: SANDOZ
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 3 May 2024
- Application: ANDA215571
- Marketing authorisation holder: LEXENPHARM
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 21 May 2024
- Application: ANDA212447
- Marketing authorisation holder: ARMSTRONG PHARMS
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 12 March 2025
- Application: ANDA218386
- Marketing authorisation holder: RITEDOSE CORP
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 April 2026
- Application: ANDA219409
- Marketing authorisation holder: CIPLA
- Local brand name: ALBUTEROL SULFATE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA
- Application: ANDA072818
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072817
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ALBUTEROL SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA073307
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Application: ANDA073495
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: ALBUTEROL SULFATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 76,311
Most-reported reactions
- Dyspnoea — 13,364 reports (17.51%)
- Wrong Technique In Product Usage Process — 11,032 reports (14.46%)
- No Adverse Event — 8,272 reports (10.84%)
- Device Delivery System Issue — 7,761 reports (10.17%)
- Drug Dose Omission By Device — 7,386 reports (9.68%)
- Asthma — 6,977 reports (9.14%)
- Cough — 6,158 reports (8.07%)
- Drug Ineffective — 5,884 reports (7.71%)
- Fatigue — 4,944 reports (6.48%)
- Headache — 4,533 reports (5.94%)
ALBUTEROL SULFATE 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 ALBUTEROL SULFATE approved in United States?
Yes. FDA authorised it on 4 May 1988; FDA authorised it on 1 February 1989; FDA authorised it on 23 March 1989.
Who is the marketing authorisation holder for ALBUTEROL SULFATE in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.