FDA — authorised 25 October 2006
- Application: NDA021703
- Marketing authorisation holder: VANTIVE US HLTHCARE
- Local brand name: PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Prismasol Bk 0/3.5 In Plastic Container in United States
FDA authorised Prismasol Bk 0/3.5 In Plastic Container on 25 October 2006
Marketing authorisations
FDA — authorised 22 May 2020
- Application: NDA208352
- Marketing authorisation holder: EVOFEM INC
- Indication: Type 3 - New Dosage Form and Type 4 - New Combination
- Status: approved
FDA
- Status: approved
Prismasol Bk 0/3.5 In Plastic Container in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Prismasol Bk 0/3.5 In Plastic Container approved in United States?
Yes. FDA authorised it on 25 October 2006; FDA authorised it on 22 May 2020; FDA has authorised it.
Who is the marketing authorisation holder for Prismasol Bk 0/3.5 In Plastic Container in United States?
VANTIVE US HLTHCARE holds the US marketing authorisation.