APPLICATION
NDA019604
TYPE
NDA
ORIGINAL APPROVAL
1992-12-23
LATEST ACTION
2001-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
VOLMAX · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 8MG BASE · TABLET, EXTENDED RELEASE · ORAL
VOLMAX · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-11-28Manufacturing (CMC) · Supplement 14 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 12 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 11 · standardAP
1998-07-27Manufacturing (CMC) · Supplement 10 · standardAP
1998-05-07Manufacturing (CMC) · Supplement 9 · standardAP
1997-11-20Labeling · Supplement 7 · standardAP
1997-10-08Efficacy · Supplement 8 · standardAP
1996-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1995-07-06Manufacturing (CMC) · Supplement 4 · standardAP
1995-03-20Manufacturing (CMC) · Supplement 5 · standardAP
1994-12-06Manufacturing (CMC) · Supplement 3 · standardAP
1994-09-21Manufacturing (CMC) · Supplement 1 · standardAP
1994-07-25Manufacturing (CMC) · Supplement 2 · standardAP
1992-12-23Type 3 - New Dosage Form · Original · standardAP
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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