FDA — authorised 15 February 1963
- Marketing authorisation holder: MEDIMETRIKS PHARMS
- Status: approved
🇺🇸 Derma-Smoothe/Fs in United States
FDA authorised Derma-Smoothe/Fs on 15 February 1963
Marketing authorisations
FDA — authorised 3 February 1988
- Application: NDA019452
- Marketing authorisation holder: HILL DERMAC
- Local brand name: DERMA-SMOOTHE/FS
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 25 April 2016
- Application: ANDA203378
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 25 April 2016
- Application: ANDA203377
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA208386
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
FDA — authorised 8 March 2017
- Application: NDA201923
- Marketing authorisation holder: ALIMERA SCIENCES INC
- Indication: Labeling
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA210539
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
Derma-Smoothe/Fs in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Derma-Smoothe/Fs approved in United States?
Yes. FDA authorised it on 15 February 1963; FDA authorised it on 3 February 1988; FDA authorised it on 25 April 2016.
Who is the marketing authorisation holder for Derma-Smoothe/Fs in United States?
MEDIMETRIKS PHARMS holds the US marketing authorisation.