APPLICATION
ANDA088656
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-22
LATEST ACTION
1997-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUIBRON-TDiscontinued
THEOPHYLLINE 300MG · TABLET · ORAL
Approval history
1997-06-23Labeling · Supplement 9AP
1997-02-07Labeling · Supplement 8AP
1996-07-22Manufacturing (CMC) · Supplement 7AP
1991-04-09Labeling · Supplement 6AP
1989-05-10Labeling · Supplement 3AP
1989-02-23Manufacturing (CMC) · Supplement 4AP
1989-02-23Manufacturing (CMC) · Supplement 5AP
1988-04-05Manufacturing (CMC) · Supplement 2AP
1985-11-26Manufacturing (CMC) · Supplement 1AP
1985-08-22OriginalAP
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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