FDA NDA · NDA019009

MAXAIR

Sponsor: BAUSCH

APPLICATION

NDA019009

TYPE

NDA

ORIGINAL APPROVAL

1986-12-30

LATEST ACTION

2001-08-14

ROUTE

INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Discontinued

Products

MAXAIRDiscontinued

PIRBUTEROL ACETATE EQ 0.2MG BASE/INH · AEROSOL, METERED · INHALATION

2001-08-14Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP

2001-04-17Manufacturing (CMC) · Supplement 7 · standardAP

1998-02-11Labeling · Supplement 5 · standardAP

1993-11-22Labeling · Supplement 4 · standardAP

1991-08-19Manufacturing (CMC) · Supplement 3 · standardAP

1986-12-30Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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