clindamycin phosphate

FDA Drug Profile — CLINDAMYCIN PHOSPHATE, Clindamycin Phosphate, clindamycin phosphate, Clindacin, Clindesse

Drug Details

Generic Name
clindamycin phosphate
Brand Names
CLINDAMYCIN PHOSPHATE, Clindamycin Phosphate, clindamycin phosphate, Clindacin, Clindesse, Cleocin Phosphate, XACIATO, Clindamycin, Cleocin, Cleocin T, CLEOCIN PHOSPHATE, Clindacin ETZ, Clindacin P
Application Number
ANDA212104
Sponsor
Padagis Israel Pharmaceuticals Ltd
NDC Codes
50
Dosage Forms
GEL, AEROSOL, FOAM, INJECTION, SOLUTION, CREAM, LOTION, SUPPOSITORY, SWAB, SOLUTION
Routes
TOPICAL, INTRAVENOUS, VAGINAL, INTRAMUSCULAR
Active Ingredients
CLINDAMYCIN PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of Use Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.