FDA — authorised 2 October 1972
- Application: NDA050441
- Marketing authorisation holder: PFIZER
- Local brand name: CLEOCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cleocin T in United States
FDA authorised Cleocin T on 2 October 1972
Marketing authorisations
FDA — authorised 2 October 1972
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
FDA — authorised 9 July 1980
- Application: NDA050537
- Marketing authorisation holder: PFIZER
- Local brand name: CLEOCIN T
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 8 February 1982
- Application: ANDA062363
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: CLEOCIN T
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 7 January 1987
- Application: NDA050615
- Marketing authorisation holder: PFIZER
- Local brand name: CLEOCIN T
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 21 April 1988
- Application: ANDA062953
- Marketing authorisation holder: HIKMA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 1988
- Application: ANDA062889
- Marketing authorisation holder: HIKMA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 May 1988
- Application: ANDA062905
- Marketing authorisation holder: LOCH
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 September 1988
- Application: ANDA062943
- Marketing authorisation holder: ALMAJECT
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 1988
- Application: ANDA062913
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 January 1989
- Application: ANDA062944
- Marketing authorisation holder: BOCA PHARMA LLC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 31 May 1989
- Application: NDA050600
- Marketing authorisation holder: PFIZER
- Local brand name: CLEOCIN T
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 28 June 1989
- Application: ANDA062930
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 August 1989
- Application: ANDA063068
- Marketing authorisation holder: HIKMA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 August 1989
- Application: NDA050639
- Marketing authorisation holder: PFIZER
- Local brand name: CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 1989
- Application: NDA050636
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 1989
- Application: NDA050635
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1989
- Application: NDA050648
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1989
- Application: ANDA063041
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1992
- Application: ANDA063282
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1992
- Application: ANDA063329
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLINDA-DERM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 30 November 1995
- Application: ANDA064050
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 30 September 1996
- Application: ANDA064136
- Marketing authorisation holder: PERRIGO CO
- Local brand name: CLINDETS
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 5 June 1997
- Application: ANDA064159
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 July 1997
- Application: ANDA063304
- Marketing authorisation holder: XTTRIUM LABS INC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 January 2000
- Application: ANDA064160
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 May 2000
- Application: ANDA065049
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 27 November 2000
- Application: NDA050782
- Marketing authorisation holder: BAUSCH
- Local brand name: CLINDAGEL
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 29 June 2001
- Application: ANDA065027
- Marketing authorisation holder: ABBOTT LABS
- Local brand name: CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 2002
- Application: ANDA065067
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 March 2004
- Application: ANDA065184
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 22 October 2004
- Application: NDA050801
- Marketing authorisation holder: NORVIUM BIOSCIENCE
- Local brand name: EVOCLIN
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 30 November 2004
- Application: NDA050793
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLINDESSE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 27 December 2004
- Application: ANDA065139
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 14 February 2006
- Application: ANDA065254
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 March 2007
- Application: ANDA065346
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 May 2007
- Application: ANDA065347
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2010
- Application: ANDA090785
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 17 June 2010
- Application: ANDA065513
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 30 September 2011
- Application: ANDA090108
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 2011
- Application: ANDA090109
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 May 2012
- Application: ANDA201692
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 April 2013
- Application: ANDA203048
- Marketing authorisation holder: RISING
- Local brand name: CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 May 2014
- Application: NDA050767
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
FDA — authorised 29 May 2015
- Application: ANDA203343
- Marketing authorisation holder: PH HEALTH
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 12 June 2015
- Application: ANDA202564
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CLINDAMYCIN PHOSPHATE AND TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA206945
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 April 2017
- Application: NDA208083
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 28 June 2017
- Application: ANDA208084
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 October 2017
- Application: ANDA204749
- Marketing authorisation holder: RISING
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 October 2017
- Application: ANDA204748
- Marketing authorisation holder: RISING
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 February 2018
- Application: ANDA209846
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA208767
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 11 March 2020
- Application: ANDA210004
- Marketing authorisation holder: TARO
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 29 July 2020
- Application: ANDA211872
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 November 2020
- Application: ANDA214052
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 December 2020
- Application: ANDA212104
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 8 March 2021
- Application: ANDA214604
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 11 March 2021
- Application: ANDA212438
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 28 June 2021
- Application: ANDA214526
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 13 August 2021
- Application: ANDA212842
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 20 September 2021
- Application: ANDA210778
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 7 December 2021
- Application: NDA215650
- Marketing authorisation holder: ORGANON LLC
- Local brand name: XACIATO
- Indication: GEL — VAGINAL
- Status: approved
FDA — authorised 18 January 2022
- Application: ANDA215607
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA212845
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: CLINDAMYCIN PHOSPHATE AND TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 November 2022
- Application: ANDA215219
- Marketing authorisation holder: AMNEAL
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 5 April 2023
- Application: ANDA214401
- Marketing authorisation holder: HIKMA
- Local brand name: CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 September 2023
- Application: ANDA216943
- Marketing authorisation holder: ENCUBE
- Local brand name: CLINDAMYCIN PHOSPHATE AND TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 September 2023
- Application: ANDA216587
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA216632
- Marketing authorisation holder: BAUSCH
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 2 April 2024
- Application: ANDA212466
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 June 2025
- Application: ANDA219612
- Marketing authorisation holder: CARNEGIE
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 18 March 2026
- Application: ANDA218942
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 23 March 2026
- Application: ANDA218300
- Marketing authorisation holder: RISING
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: SOLUTION — TOPICAL
- Status: approved
The FDA approved Cleocin T (clindamycin phosphate) topical solution for the treatment of acne. The approval was granted to Rising, the marketing authorisation holder, following a standard review pathway. The product is indicated for the treatment of acne, and its approval is based on the available data demonstrating its safety and efficacy.
FDA
- Application: ANDA062900
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062908
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062852
- Marketing authorisation holder: SOLOPAK
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA063079
- Marketing authorisation holder: WATSON LABS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062747
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062928
- Marketing authorisation holder: IGI LABS INC
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062877
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA063163
- Marketing authorisation holder: BEDFORD
- Local brand name: CLINDAMYCIN PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Cleocin T 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 Cleocin T approved in United States?
Yes. FDA authorised it on 2 October 1972; FDA authorised it on 2 October 1972; FDA authorised it on 9 July 1980.
Who is the marketing authorisation holder for Cleocin T in United States?
PFIZER holds the US marketing authorisation.