APPLICATION
ANDA072780
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-25
LATEST ACTION
1998-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
Approval history
1998-10-20Manufacturing (CMC) · Supplement 4AP
1998-05-14Labeling · Supplement 3AP
1994-02-04Manufacturing (CMC) · Supplement 2AP
1993-07-15Labeling · Supplement 1AP
1993-06-25OriginalAP
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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