APPLICATION
ANDA074880
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-17
LATEST ACTION
2007-03-28
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 0.083% BASE · SOLUTION · INHALATION
Approval history
2007-03-28Labeling · Supplement 12AP
2001-06-06Manufacturing (CMC) · Supplement 11AP
2001-06-06Manufacturing (CMC) · Supplement 10AP
2000-08-17Labeling · Supplement 7AP
2000-08-17Manufacturing (CMC) · Supplement 8AP
1999-10-29Manufacturing (CMC) · Supplement 5AP
1999-07-21Manufacturing (CMC) · Supplement 3AP
1998-10-26Labeling · Supplement 2AP
1997-11-20Labeling · Supplement 1AP
1997-09-17OriginalAP
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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