← FDA DRUG APPROVALS

FDA NDA · NDA208685

EMFLAZA

deflazacort

Sponsor: PTC THERAP

APPLICATION
NDA208685
TYPE
NDA
ORIGINAL APPROVAL
2017-02-09
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

EMFLAZA · ReferencePrescription
DEFLAZACORT 22.75MG/ML · SUSPENSION · ORAL

Approval history

2024-06-05Labeling · Supplement 7 · standard — Label ↗AP
2021-06-29Labeling · Supplement 5 · standard — Letter ↗AP
2020-07-10Labeling · Supplement 4 · standard — Label ↗AP
2019-06-07Efficacy · Supplement 3 · priority — Label ↗AP
2017-02-09Type 1 - New Molecular Entity · Original · priority — Letter ↗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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