APPLICATION
NDA013296
TYPE
NDA
ORIGINAL APPROVAL
1973-08-20
LATEST ACTION
2009-03-13
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
DUO-MEDIHALERDiscontinued
ISOPROTERENOL HYDROCHLORIDE 0.16MG/INH, PHENYLEPHRINE BITARTRATE 0.24MG/INH · AEROSOL, METERED · INHALATION
Approval history
2009-03-13Labeling · Supplement 8AP
1994-02-23Labeling · Supplement 13 · standardAP
1987-02-27Labeling · Supplement 11AP
1984-05-21Manufacturing (CMC) · Supplement 10 · standardAP
1982-03-05Manufacturing (CMC) · Supplement 9 · standardAP
1973-08-20Type 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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