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FDA NDA · NDA202813

QNASL

beclomethasone dipropionate

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA202813
TYPE
NDA
ORIGINAL APPROVAL
2012-03-23
LATEST ACTION
2018-03-30
ROUTE
NASAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

QNASL · ReferencePrescription
BECLOMETHASONE DIPROPIONATE 0.04MG/ACTUATION · AEROSOL, METERED · NASAL
QNASL · ReferencePrescription
BECLOMETHASONE DIPROPIONATE 0.08MG/ACTUATION · AEROSOL, METERED · NASAL

Approval history

2018-03-30Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2017-07-26Labeling · Supplement 11 · standard — Label ↗AP
2016-02-29Manufacturing (CMC) · Supplement 10 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 4 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 8 · standardAP
2014-12-17Efficacy · Supplement 9 · standard — Label ↗AP
2014-12-17Efficacy · Supplement 7 · standard — Label ↗AP
2014-07-10Labeling · Supplement 6 · standard — Letter ↗AP
2014-03-19Labeling · Supplement 5 · standard — Label ↗AP
2013-08-29Manufacturing (CMC) · Supplement 3 · standardAP
2012-03-23Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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