APPLICATION
ANDA075050
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-18
LATEST ACTION
2017-03-31
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.5% BASE · SOLUTION · INHALATION
Approval history
2017-03-31Labeling · Supplement 17 · standardAP
2001-11-27Manufacturing (CMC) · Supplement 9AP
2001-03-07Manufacturing (CMC) · Supplement 7AP
2000-06-27Manufacturing (CMC) · Supplement 6AP
2000-05-18Manufacturing (CMC) · Supplement 2AP
2000-04-28Manufacturing (CMC) · Supplement 3AP
1999-12-29Manufacturing (CMC) · Supplement 5AP
1999-12-29Labeling · Supplement 4AP
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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