FDA — authorised 18 May 1949
- Application: NDA006823
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: AQUASOL A
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Aquasol A in United States
FDA authorised Aquasol A on 18 May 1949 · 13 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA083080
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: AQUASOL A
- Indication: CAPSULE — ORAL
- 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: 22 April 2025 – 22 April 2026
- Total reports: 13
Most-reported reactions
- Medication Error — 4 reports (30.77%)
- Abdominal Discomfort — 1 report (7.69%)
- Abdominal Distension — 1 report (7.69%)
- Alopecia — 1 report (7.69%)
- Apnoea — 1 report (7.69%)
- Appetite Disorder — 1 report (7.69%)
- Bacterial Infection — 1 report (7.69%)
- Cervical Polyp — 1 report (7.69%)
- Clavicle Fracture — 1 report (7.69%)
- Contusion — 1 report (7.69%)
Frequently asked questions
Is Aquasol A approved in United States?
Yes. FDA authorised it on 18 May 1949; FDA has authorised it.
Who is the marketing authorisation holder for Aquasol A in United States?
CASPER PHARMA LLC holds the US marketing authorisation.