APPLICATION
ANDA078623
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-05
LATEST ACTION
2023-02-02
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.021% BASE · SOLUTION · INHALATION
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.042% BASE · SOLUTION · INHALATION
Approval history
2023-02-02Labeling · Supplement 2 · standardAP
2014-02-28Labeling · Supplement 1 · standardAP
2010-04-05OriginalAP
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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