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FDA NDA · NDA207589

ENSTILAR

calcipotriene and betamethasone dipropionate

Sponsor: LEO PHARMA AS

APPLICATION
NDA207589
TYPE
NDA
ORIGINAL APPROVAL
2015-10-16
LATEST ACTION
2021-08-06
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Prescription

Products

ENSTILAR · ReferencePrescription
BETAMETHASONE DIPROPIONATE 0.064%, CALCIPOTRIENE 0.005% · AEROSOL, FOAM · TOPICAL

Approval history

2021-08-06Labeling · Supplement 11 · standard — Label ↗AP
2020-10-16Efficacy · Supplement 10 · standard — Letter ↗AP
2019-07-30Labeling · Supplement 6 · standard — Letter ↗AP
2019-07-30Labeling · Supplement 7 · standard — Letter ↗AP
2019-07-30Efficacy · Supplement 5 · priority — Letter ↗AP
2016-06-20Manufacturing (CMC) · Supplement 2 · standardAP
2016-03-08Labeling · Supplement 1 · standard — Label ↗AP
2015-10-16Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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