← FDA DRUG APPROVALS

FDA NDA · NDA214902

TWYNEO

tretinoin and benzoyl peroxide

Sponsor: MAYNE PHARMA

APPLICATION
NDA214902
TYPE
NDA
ORIGINAL APPROVAL
2021-07-26
LATEST ACTION
2021-07-26
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

TWYNEO · ReferencePrescription
BENZOYL PEROXIDE 3%, TRETINOIN 0.1% · CREAM · TOPICAL

Approval history

2021-07-26Type 4 - New Combination · Original · standardLabelAP
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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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