Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050819

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

Active Ingredient: BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Proprietary Name: ACANYA
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 2.5%;EQ 1.2% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050819
Product Number: 001
Approval Date: Oct 23, 2008
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ONEXTON (BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE)
3.75%;EQ 1.2% BASE
Marketing Status: Prescription

Active Ingredient: BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Proprietary Name: ONEXTON
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 3.75%;EQ 1.2% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050819
Product Number: 002
Approval Date: Nov 24, 2014
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information