FDA — authorised 23 December 1982
- Status: approved
🇺🇸 Spectazole in United States
FDA authorised Spectazole on 23 December 1982
Marketing authorisations
FDA — authorised 23 December 1982
- Application: NDA018751
- Marketing authorisation holder: ALVOGEN
- Local brand name: SPECTAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 23 June 2004
- Application: ANDA076479
- Marketing authorisation holder: PADAGIS ISRAEL
- Status: approved
FDA — authorised 18 November 2019
- Application: NDA205175
- Marketing authorisation holder: RESILIA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 8 June 2020
- Application: ANDA076005
- Marketing authorisation holder: SUN PHARMA CANADA
- Indication: Labeling
- Status: approved
FDA — authorised 8 June 2020
- Application: ANDA210364
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
Spectazole in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Spectazole approved in United States?
Yes. FDA authorised it on 23 December 1982; FDA authorised it on 23 December 1982; FDA authorised it on 23 June 2004.
Who is the marketing authorisation holder for Spectazole in United States?
Marketing authorisation holder not available in our data.