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FDA ANDA · ANDA214185

ADAPALENE AND BENZOYL PEROXIDE

adapalene and benzoyl peroxide topical

Sponsor: ALEMBIC

APPLICATION
ANDA214185
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-04
LATEST ACTION
2025-08-18
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

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

Approval history

2025-08-18Manufacturing (CMC) · Supplement 3 · unknownAP
2022-08-04UNKNOWN · Original · standardAP
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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.

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