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FDA NDA · NDA017559

PROVENTIL

Sponsor: SCHERING

APPLICATION
NDA017559
TYPE
NDA
ORIGINAL APPROVAL
1981-05-01
LATEST ACTION
2006-09-07
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

PROVENTILDiscontinued
ALBUTEROL 0.09MG/INH · AEROSOL, METERED · INHALATION

Approval history

2006-09-07Labeling · Supplement 40 · priority — Letter ↗AP
2000-12-04Manufacturing (CMC) · Supplement 32 · priorityAP
1999-03-11Manufacturing (CMC) · Supplement 27 · priorityAP
1998-11-09Labeling · Supplement 23 · priority — Review ↗AP
1996-09-09Manufacturing (CMC) · Supplement 21 · priorityAP
1992-12-15Manufacturing (CMC) · Supplement 18 · priorityAP
1989-01-24Manufacturing (CMC) · Supplement 16 · priorityAP
1986-08-29Manufacturing (CMC) · Supplement 14 · priorityAP
1986-07-08Manufacturing (CMC) · Supplement 12 · priorityAP
1986-04-22Labeling · Supplement 10 · priorityAP
1986-03-06Manufacturing (CMC) · Supplement 11 · priorityAP
1985-07-02Manufacturing (CMC) · Supplement 8 · priorityAP
1985-07-02Labeling · Supplement 9 · priorityAP
1985-04-12Labeling · Supplement 7 · priorityAP
1985-02-21Manufacturing (CMC) · Supplement 6 · priorityAP
1984-12-04Manufacturing (CMC) · Supplement 4 · priorityAP
1984-09-13Efficacy · Supplement 5 · priorityAP
1982-03-16Manufacturing (CMC) · Supplement 3 · priorityAP
1981-11-02Labeling · Supplement 2 · priorityAP
1981-11-02Manufacturing (CMC) · Supplement 1 · priorityAP
1981-05-01Type 1 - New Molecular Entity · Original · priorityAP
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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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