FDA — authorised 26 October 1984
- Application: NDA050557
- Marketing authorisation holder: VALEANT INTL
- Local brand name: BENZAMYCIN
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Benzamycin in United States
FDA authorised Benzamycin on 26 October 1984
Marketing authorisations
FDA — authorised 27 November 2000
- Application: NDA050769
- Marketing authorisation holder: BIOFRONTERA
- Local brand name: AKTIPAK
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 29 March 2004
- Application: ANDA065112
- Marketing authorisation holder: ENCUBE
- Local brand name: ERYTHROMYCIN AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 11 August 2009
- Application: ANDA065443
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 June 2012
- Application: ANDA090979
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 June 2015
- Application: ANDA205128
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 18 September 2015
- Application: ANDA065385
- Marketing authorisation holder: RISING
- Local brand name: ERYTHROMYCIN AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 21 September 2015
- Application: ANDA202440
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 August 2016
- Application: ANDA203688
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 27 June 2017
- Application: ANDA204087
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 May 2018
- Application: ANDA208776
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 5 June 2018
- Application: ANDA208683
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 28 December 2018
- Application: ANDA210794
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 August 2019
- Application: ANDA207194
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 August 2019
- Application: ANDA206575
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 9 September 2019
- Application: ANDA205397
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 28 April 2021
- Application: ANDA212433
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 July 2021
- Application: NDA214902
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: TWYNEO
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 April 2022
- Application: NDA214510
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: EPSOLAY
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA216632
- Marketing authorisation holder: BAUSCH
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 18 August 2025
- Application: ANDA214185
- Marketing authorisation holder: ALEMBIC
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Benzamycin, manufactured by ALEMBIC, on 18 August 2025. This approval was granted under the standard expedited pathway. The marketing authorisation is for the manufacturing (CMC) indication, as per the ANDA214185 application.
FDA
- Application: ANDA208757
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: BENZOYL PEROXIDE AND CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
Benzamycin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Benzamycin approved in United States?
Yes. FDA authorised it on 26 October 1984; FDA authorised it on 27 November 2000; FDA authorised it on 29 March 2004.
Who is the marketing authorisation holder for Benzamycin in United States?
VALEANT INTL holds the US marketing authorisation.