APPLICATION
ANDA072317
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-30
LATEST ACTION
2000-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
Approval history
2000-07-07Manufacturing (CMC) · Supplement 10AP
1998-05-20Labeling · Supplement 9AP
1996-08-01Manufacturing (CMC) · Supplement 8AP
1996-03-05Manufacturing (CMC) · Supplement 7AP
1995-12-22Labeling · Supplement 6AP
1994-05-17Labeling · Supplement 5AP
1994-05-17Labeling · Supplement 4AP
1994-05-11Manufacturing (CMC) · Supplement 3AP
1992-06-04Labeling · Supplement 2AP
1991-01-16Labeling · Supplement 1AP
1989-01-30OriginalAP
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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