← FDA DRUG APPROVALS

FDA NDA · NDA020911

QVAR 80

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA020911
TYPE
NDA
ORIGINAL APPROVAL
2000-09-15
LATEST ACTION
2017-09-29
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

QVAR 80 · ReferenceDiscontinued
BECLOMETHASONE DIPROPIONATE 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, METERED · INHALATION
QVAR 40 · ReferenceDiscontinued
BECLOMETHASONE DIPROPIONATE 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, METERED · INHALATION

Approval history

2017-09-29Labeling · Supplement 29 · standard — Label ↗AP
2017-09-29Labeling · Supplement 30 · standard — Label ↗AP
2015-12-16Manufacturing (CMC) · Supplement 27 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 24 · standardAP
2014-07-21Labeling · Supplement 25 · standard — Label ↗AP
2014-05-22Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP
2013-05-08Manufacturing (CMC) · Supplement 23 · standardAP
2012-07-30Labeling · Supplement 22 · standard — Letter ↗AP
2008-08-18Labeling · Supplement 17 · standard — Letter ↗AP
2006-11-20Labeling · Supplement 15 · standard — Label ↗AP
2003-08-01Labeling · Supplement 8 · standard — Letter ↗AP
2002-07-11Manufacturing (CMC) · Supplement 7 · standardAP
2002-05-10Efficacy · Supplement 5 · standard — Letter ↗AP
2002-01-17Manufacturing (CMC) · Supplement 6 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 4 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 3 · standardAP
2001-03-27Manufacturing (CMC) · Supplement 2 · standardAP
2001-02-01Manufacturing (CMC) · Supplement 1 · standardAP
2000-09-15Type 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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