FDA — authorised 26 June 1984
- Application: NDA019138
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: ALPHATREX
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Diprolene in United States
FDA authorised Diprolene on 26 June 1984
Marketing authorisations
FDA — authorised 26 June 1984
- Application: NDA019137
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 July 1985
- Application: ANDA070281
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 January 1986
- Application: NDA019408
- Marketing authorisation holder: SCHERING
- Local brand name: DIPROLENE
- Indication: GEL, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 3 February 1987
- Application: ANDA071012
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 27 April 1987
- Application: NDA019555
- Marketing authorisation holder: ORGANON
- Local brand name: DIPROLENE AF
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 10 August 1987
- Application: ANDA071476
- Marketing authorisation holder: TEVA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 August 1987
- Application: ANDA071467
- Marketing authorisation holder: COSETTE
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 1 August 1988
- Application: NDA019716
- Marketing authorisation holder: ORGANON
- Local brand name: DIPROLENE
- Indication: LOTION, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 31 January 1990
- Application: ANDA072538
- Marketing authorisation holder: PADAGIS US
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 30 April 1992
- Application: ANDA073552
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 September 1994
- Application: ANDA074271
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 September 1994
- Application: ANDA074272
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 August 1995
- Application: ANDA074304
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA074579
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 December 2000
- Application: NDA020010
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: LOTRISONE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 5 June 2001
- Application: ANDA075502
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 May 2003
- Application: ANDA075276
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: GEL, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 2 December 2003
- Application: ANDA076508
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: GEL, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 9 December 2003
- Application: ANDA076543
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 9 December 2003
- Application: ANDA076592
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 9 December 2003
- Application: ANDA076215
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 23 January 2004
- Application: ANDA076603
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 28 July 2004
- Application: ANDA076493
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 12 October 2004
- Application: ANDA076753
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 16 June 2005
- Application: ANDA076516
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 21 May 2007
- Application: ANDA077477
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 21 May 2007
- Application: ANDA077111
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 23 September 2008
- Application: ANDA078930
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 12 December 2014
- Application: ANDA200174
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Not Applicable
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA202894
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 March 2016
- Application: NDA207589
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2018
- Application: ANDA206389
- Marketing authorisation holder: ENCUBE
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 18 December 2019
- Application: ANDA209106
- Marketing authorisation holder: LUPIN
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 9 June 2020
- Application: ANDA075373
- Marketing authorisation holder: FOUGERA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 17 June 2020
- Application: ANDA211722
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: SPRAY — TOPICAL
- Status: approved
FDA — authorised 14 July 2020
- Application: ANDA214048
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 11 September 2020
- Application: ANDA212367
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA215186
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 April 2024
- Application: ANDA218289
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT, AUGMENTED — TOPICAL
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA219348
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
Aurobindo Pharma Ltd has been granted marketing authorisation by the FDA for Diprolene (betamethasone dipropionate) cream for topical use. This approval was granted on 26 January 2026, following a standard expedited pathway. Diprolene is indicated for the treatment of various skin conditions.
FDA
- Application: ANDA072536
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: NDA019136
- Marketing authorisation holder: PHARMADERM
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA071085
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Application: ANDA072526
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: NDA019140
- Marketing authorisation holder: PHARMADERM
- Local brand name: BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
Diprolene 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 Diprolene approved in United States?
Yes. FDA authorised it on 26 June 1984; FDA authorised it on 26 June 1984; FDA authorised it on 31 July 1985.
Who is the marketing authorisation holder for Diprolene in United States?
SAVAGE LABS holds the US marketing authorisation.