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FDA ANDA · ANDA072151

ALBUTEROL SULFATE

Sponsor: CHARTWELL RX

APPLICATION
ANDA072151
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-23
LATEST ACTION
2002-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL

Approval history

2002-04-19Manufacturing (CMC) · Supplement 18AP
2002-02-07Manufacturing (CMC) · Supplement 16AP
2001-12-13Manufacturing (CMC) · Supplement 17AP
2000-11-30Manufacturing (CMC) · Supplement 15AP
1999-05-05Manufacturing (CMC) · Supplement 14AP
1998-04-23Labeling · Supplement 13AP
1997-11-05Manufacturing (CMC) · Supplement 12AP
1995-12-07Manufacturing (CMC) · Supplement 11AP
1994-08-23Manufacturing (CMC) · Supplement 6AP
1994-08-23Labeling · Supplement 10AP
1994-08-23Manufacturing (CMC) · Supplement 7AP
1994-08-23Manufacturing (CMC) · Supplement 5AP
1994-01-24Manufacturing (CMC) · Supplement 9AP
1993-10-06Labeling · Supplement 4AP
1991-05-10Labeling · Supplement 3AP
1990-12-18Labeling · Supplement 2AP
1989-03-23OriginalAP
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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