← FDA DRUG APPROVALS

FDA ANDA · ANDA209641

ADAPALENE AND BENZOYL PEROXIDE

Sponsor: ACTAVIS LABS UT INC

APPLICATION
ANDA209641
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-22
LATEST ACTION
2022-06-22
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ADAPALENE AND BENZOYL PEROXIDEPrescription
ADAPALENE 0.3%, BENZOYL PEROXIDE 2.5% · GEL · TOPICAL

Approval history

2022-06-22UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →