APPLICATION
ANDA075394
TYPE
ANDA
ORIGINAL APPROVAL
1999-11-22
LATEST ACTION
2001-10-15
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE · SOLUTION · INHALATION
Approval history
2001-10-15Manufacturing (CMC) · Supplement 4AP
2001-05-30Manufacturing (CMC) · Supplement 2AP
2001-05-30Manufacturing (CMC) · Supplement 3AP
2001-05-30Labeling · Supplement 1AP
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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