APPLICATION
ANDA072894
TYPE
ANDA
ORIGINAL APPROVAL
1991-01-17
LATEST ACTION
1998-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
Approval history
1998-07-16Labeling · Supplement 7AP
1998-02-05Manufacturing (CMC) · Supplement 6AP
1993-10-29Manufacturing (CMC) · Supplement 5AP
1993-02-18Labeling · Supplement 3AP
1992-11-05Labeling · Supplement 2AP
1992-09-23Manufacturing (CMC) · Supplement 1AP
1991-01-17OriginalAP
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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