FDA — authorised 17 February 1969
- Application: NDA016740
- Marketing authorisation holder: SCHERING
- Local brand name: VALISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Betamethasone Valerate in United States
FDA authorised Betamethasone Valerate on 17 February 1969
Marketing authorisations
FDA — authorised 10 January 1973
- Application: NDA016932
- Marketing authorisation holder: SCHERING
- Local brand name: VALISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 30 June 1983
- Application: NDA018839
- Marketing authorisation holder: ROACO
- Local brand name: BETADERM
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 August 1983
- Application: NDA018865
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: BETAMETHASONE VALERATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 August 1983
- Application: NDA018867
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: BETATREX
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 August 1983
- Application: NDA018866
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: BETAMETHASONE VALERATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 10 October 1984
- Application: ANDA070051
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: BETAMETHASONE VALERATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 October 1984
- Application: ANDA070050
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: VALNAC
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 May 1985
- Application: ANDA070062
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE VALERATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 June 1985
- Application: ANDA070072
- Marketing authorisation holder: COSETTE
- Local brand name: BETA-VAL
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 July 1985
- Application: ANDA070052
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: BETAMETHASONE VALERATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 19 December 1985
- Application: ANDA070069
- Marketing authorisation holder: COSETTE
- Local brand name: BETA-VAL
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 April 1987
- Application: NDA018861
- Marketing authorisation holder: FOUGERA PHARMS INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 January 1988
- Application: ANDA072041
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DERMABET
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 July 1988
- Application: NDA018642
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 12 August 1992
- Application: ANDA070053
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: BETAMETHASONE VALERATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 November 2012
- Application: ANDA078337
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: BETAMETHASONE VALERATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 24 May 2017
- Application: ANDA208204
- Marketing authorisation holder: TARO
- Local brand name: BETAMETHASONE VALERATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 24 May 2017
- Application: ANDA207144
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: BETAMETHASONE VALERATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA210639
- Marketing authorisation holder: XIROMED
- Local brand name: BETAMETHASONE VALERATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA215832
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA
- Application: NDA018870
- Marketing authorisation holder: PHARMADERM
- Local brand name: BETAMETHASONE VALERATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: NDA018864
- Marketing authorisation holder: PHARMADERM
- Local brand name: BETAMETHASONE VALERATE
- Indication: OINTMENT — TOPICAL
- Status: approved
Betamethasone Valerate 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 Betamethasone Valerate approved in United States?
Yes. FDA authorised it on 17 February 1969; FDA authorised it on 10 January 1973; FDA authorised it on 30 June 1983.
Who is the marketing authorisation holder for Betamethasone Valerate in United States?
SCHERING holds the US marketing authorisation.