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FDA ANDA · ANDA073419

ALBUTEROL SULFATE

Sponsor: TEVA

APPLICATION
ANDA073419
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-30
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

ALBUTEROL SULFATEPrescription
ALBUTEROL SULFATE EQ 2MG BASE/5ML · SYRUP · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 26AP
2000-07-27Labeling · Supplement 25AP
2000-07-07Manufacturing (CMC) · Supplement 24AP
1998-05-27Manufacturing (CMC) · Supplement 22AP
1998-05-27Manufacturing (CMC) · Supplement 21AP
1998-05-06Labeling · Supplement 23AP
1997-10-07Manufacturing (CMC) · Supplement 20AP
1997-01-08Manufacturing (CMC) · Supplement 19AP
1996-08-16Manufacturing (CMC) · Supplement 18AP
1995-10-12Labeling · Supplement 17AP
1995-05-04Manufacturing (CMC) · Supplement 16AP
1995-05-04Manufacturing (CMC) · Supplement 15AP
1995-02-22Labeling · Supplement 14AP
1995-02-02Manufacturing (CMC) · Supplement 11AP
1995-02-02Manufacturing (CMC) · Supplement 13AP
1994-09-22Manufacturing (CMC) · Supplement 12AP
1994-08-08Labeling · Supplement 10AP
1993-12-03Manufacturing (CMC) · Supplement 8AP
1993-08-09Manufacturing (CMC) · Supplement 7AP
1993-05-28Manufacturing (CMC) · Supplement 3AP
1993-05-25Manufacturing (CMC) · Supplement 5AP
1993-05-25Manufacturing (CMC) · Supplement 4AP
1993-04-01Manufacturing (CMC) · Supplement 6AP
1992-12-30Manufacturing (CMC) · Supplement 2AP
1992-03-30OriginalAP
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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