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FDA ANDA · ANDA072619

ALBUTEROL SULFATE

Sponsor: TEVA

APPLICATION
ANDA072619
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-07
LATEST ACTION
1998-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL

Approval history

1998-06-12Labeling · Supplement 15AP
1997-06-18Manufacturing (CMC) · Supplement 14AP
1995-02-16Manufacturing (CMC) · Supplement 12AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-09-06Manufacturing (CMC) · Supplement 11AP
1994-06-17Manufacturing (CMC) · Supplement 10AP
1994-04-21Manufacturing (CMC) · Supplement 8AP
1994-04-21Manufacturing (CMC) · Supplement 9AP
1993-11-15Manufacturing (CMC) · Supplement 7AP
1993-03-01Labeling · Supplement 6AP
1992-11-05Labeling · Supplement 4AP
1992-03-06Manufacturing (CMC) · Supplement 3AP
1991-06-18Labeling · Supplement 2AP
1991-01-17Labeling · Supplement 1AP
1989-04-07OriginalAP
VIEW ON DRUGS@FDA ↗

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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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