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FDA ANDA · ANDA073533

ALBUTEROL SULFATE

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA073533
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-26
LATEST ACTION
2002-01-25
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE · SOLUTION · INHALATION

Approval history

2002-01-25Manufacturing (CMC) · Supplement 16AP
2001-04-03Manufacturing (CMC) · Supplement 14AP
2000-08-17Labeling · Supplement 13AP
2000-08-17Manufacturing (CMC) · Supplement 11AP
2000-08-17Manufacturing (CMC) · Supplement 12AP
2000-03-21Manufacturing (CMC) · Supplement 10AP
1999-07-20Manufacturing (CMC) · Supplement 9AP
1999-07-16Manufacturing (CMC) · Supplement 5AP
1999-07-16Manufacturing (CMC) · Supplement 3AP
1999-07-16Manufacturing (CMC) · Supplement 6AP
1999-07-16Manufacturing (CMC) · Supplement 4AP
1999-07-16Manufacturing (CMC) · Supplement 2AP
1999-07-16Manufacturing (CMC) · Supplement 7AP
1998-04-23Labeling · Supplement 8AP
1997-01-28Manufacturing (CMC) · Supplement 1AP
1995-09-26OriginalAP
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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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