FDA NDA · NDA018340

AEROBID

Sponsor: ROCHE PALO

APPLICATION

NDA018340

TYPE

NDA

ORIGINAL APPROVAL

1984-08-17

LATEST ACTION

2003-11-26

ROUTE

INHALATION

DOSAGE FORM

AEROSOL, METERED

MARKETING STATUS

Discontinued

Products

AEROBIDDiscontinued

FLUNISOLIDE 0.25MG/INH · AEROSOL, METERED · INHALATION

2003-11-26Labeling · Supplement 21 · standard — Letter ↗AP

1995-05-08Manufacturing (CMC) · Supplement 16 · standardAP

1994-08-17Manufacturing (CMC) · Supplement 12 · standardAP

1994-08-05Manufacturing (CMC) · Supplement 13 · standardAP

1993-10-26Manufacturing (CMC) · Supplement 11 · standardAP

1992-02-19Manufacturing (CMC) · Supplement 9 · standardAP

1989-08-25Manufacturing (CMC) · Supplement 2 · standardAP

1989-01-06Manufacturing (CMC) · Supplement 8 · standardAP

1987-12-23Manufacturing (CMC) · Supplement 7 · standardAP

1986-08-18Manufacturing (CMC) · Supplement 3 · standardAP

1984-08-17Type 3 - New Dosage Form · 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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