APPLICATION
ANDA072637
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-01
LATEST ACTION
2002-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL
Approval history
2002-12-11Manufacturing (CMC) · Supplement 17AP
2002-07-03Manufacturing (CMC) · Supplement 16AP
2002-05-01Manufacturing (CMC) · Supplement 14AP
2002-03-04Manufacturing (CMC) · Supplement 15AP
2000-05-16Manufacturing (CMC) · Supplement 12AP
2000-05-16Manufacturing (CMC) · Supplement 13AP
1998-06-12Labeling · Supplement 11AP
1997-12-05Manufacturing (CMC) · Supplement 10AP
1997-02-24Manufacturing (CMC) · Supplement 9AP
1995-06-22Manufacturing (CMC) · Supplement 8AP
1994-01-12Manufacturing (CMC) · Supplement 7AP
1993-10-25Manufacturing (CMC) · Supplement 6AP
1993-02-09Labeling · Supplement 5AP
1992-11-05Labeling · Supplement 4AP
1991-02-04Labeling · Supplement 3AP
1990-08-29Labeling · Supplement 2AP
1989-03-22Labeling · Supplement 1AP
1989-02-01OriginalAP
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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