FDA NDA · NDA020291

COMBIVENT

Sponsor: BOEHRINGER INGELHEIM

APPLICATION

NDA020291

TYPE

NDA

ORIGINAL APPROVAL

1996-10-24

LATEST ACTION

2012-09-17

ROUTE

INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Discontinued

Products

COMBIVENTDiscontinued

ALBUTEROL SULFATE EQ 0.09MG BASE/INH, IPRATROPIUM BROMIDE 0.018MG/INH · AEROSOL, METERED · INHALATION

2012-09-17Labeling · Supplement 30 · unknown — Letter ↗AP

2012-08-20Labeling · Supplement 31 · unknown — Label ↗AP

2011-04-01Labeling · Supplement 29 · unknown — Letter ↗AP

2009-06-02Labeling · Supplement 27 · standard — Letter ↗AP

2009-05-07Labeling · Supplement 26 · standard — Label ↗AP

2008-11-10Labeling · Supplement 23 · standard — Letter ↗AP

2006-06-01Labeling · Supplement 20 · standard — Letter ↗AP

2001-07-23Manufacturing (CMC) · Supplement 12 · standardAP

1999-09-16Manufacturing (CMC) · Supplement 11 · standardAP

1999-08-18Manufacturing (CMC) · Supplement 9 · standardAP

1999-03-23Manufacturing (CMC) · Supplement 5 · standardAP

1999-02-22Manufacturing (CMC) · Supplement 7 · standardAP

1998-06-19Manufacturing (CMC) · Supplement 6 · standardAP

1997-11-26Manufacturing (CMC) · Supplement 3 · standardAP

1997-10-14Manufacturing (CMC) · Supplement 2 · standardAP

1997-04-08Manufacturing (CMC) · Supplement 1 · standardAP

1996-10-24Type 4 - New Combination · Original · standardAP

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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