Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 205128

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE)
2.5%;EQ 1.2% BASE Marketing Status: Prescription

Active Ingredient: BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Proprietary Name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 2.5%;EQ 1.2% BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205128
Product Number: 001
Approval Date: Jun 19, 2015
Applicant Holder Full Name: ACTAVIS LABORATORIES UT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English