APPLICATION
ANDA086399
TYPE
ANDA
ORIGINAL APPROVAL
1980-05-30
LATEST ACTION
1998-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THEOLAIRDiscontinued
THEOPHYLLINE 250MG · TABLET · ORAL
THEOLAIRDiscontinued
THEOPHYLLINE 125MG · TABLET · ORAL
Approval history
1998-10-20Manufacturing (CMC) · Supplement 15AP
1998-01-20Manufacturing (CMC) · Supplement 14AP
1996-09-20Labeling · Supplement 13AP
1993-07-08Manufacturing (CMC) · Supplement 12AP
1990-09-18Labeling · Supplement 10AP
1984-06-22Manufacturing (CMC) · Supplement 5AP
1980-05-30OriginalAP
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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