FDA — authorised 12 April 1950
- Application: NDA007337
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: PERCODAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Acetyl Salicylic acid in United States
FDA authorised Acetyl Salicylic acid on 12 April 1950 · 169 US adverse-event reports
Marketing authorisations
FDA — authorised 27 May 1960
- Application: NDA011702
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: EQUAGESIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 1960
- Application: NDA012365
- Marketing authorisation holder: MEDA PHARMS
- Local brand name: SOMA COMPOUND
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 1964
- Application: NDA013416
- Marketing authorisation holder: BAUSCH
- Local brand name: NORGESIC FORTE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1965
- Application: NDA016030
- Marketing authorisation holder: BAYER
- Local brand name: 8-HOUR BAYER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 September 1975
- Application: ANDA084553
- Marketing authorisation holder: ALRA
- Local brand name: COMPOUND 65
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 May 1976
- Application: NDA017534
- Marketing authorisation holder: ALLERGAN
- Local brand name: FIORINAL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1982
- Application: ANDA087211
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHOCARBAMOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 1986
- Application: ANDA089193
- Marketing authorisation holder: MCNEIL
- Local brand name: METHOCARBAMOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 1988
- Application: ANDA089657
- Marketing authorisation holder: PAR PHARM
- Local brand name: METHOCARBAMOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 1989
- Application: ANDA089594
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CARISOPRODOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1995
- Application: ANDA081145
- Marketing authorisation holder: STEVENS J
- Local brand name: METHOCARBAMOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1997
- Application: ANDA040252
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: CARISOPRODOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1998
- Application: ANDA040255
- Marketing authorisation holder: ANI PHARMS
- Local brand name: OXYCODONE AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 1998
- Application: ANDA075141
- Marketing authorisation holder: GALT PHARMS
- Local brand name: ORPHENGESIC FORTE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2010
- Application: ANDA040832
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CARISOPRODOL AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA090084
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: OXYCODONE AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2013
- Application: NDA203697
- Marketing authorisation holder: PLX PHARMA
- Local brand name: VAZALORE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 July 2020
- Application: ANDA040910
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXYCODONE AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 2021
- Application: ANDA205479
- Marketing authorisation holder: LGM PHARMA
- Local brand name: HYDROCODONE BITARTRATE AND ASPIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA209791
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: ASPIRIN; OMEPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088305
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: AXOTAL
- Indication: TABLET — ORAL
- 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: 169
Most-reported reactions
- Drug Interaction — 23 reports (13.61%)
- Dyspnoea — 19 reports (11.24%)
- Malaise — 18 reports (10.65%)
- Nausea — 18 reports (10.65%)
- Drug Ineffective — 17 reports (10.06%)
- Fall — 17 reports (10.06%)
- Rhabdomyolysis — 15 reports (8.88%)
- Atrial Fibrillation — 14 reports (8.28%)
- Myocardial Infarction — 14 reports (8.28%)
- Pyrexia — 14 reports (8.28%)
Acetyl Salicylic acid 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 Acetyl Salicylic acid approved in United States?
Yes. FDA authorised it on 12 April 1950; FDA authorised it on 27 May 1960; FDA authorised it on 12 September 1960.
Who is the marketing authorisation holder for Acetyl Salicylic acid in United States?
ENDO OPERATIONS holds the US marketing authorisation.