APPLICATION
ANDA086107
TYPE
ANDA
ORIGINAL APPROVAL
1979-03-26
LATEST ACTION
1996-09-20
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
THEOLAIRDiscontinued
THEOPHYLLINE 80MG/15ML · SOLUTION · ORAL
Approval history
1996-09-20Labeling · Supplement 8AP
1991-06-12Labeling · Supplement 6AP
1985-06-18Manufacturing (CMC) · Supplement 4AP
1985-06-18Manufacturing (CMC) · Supplement 5AP
1983-02-18Manufacturing (CMC) · Supplement 1AP
1979-03-26OriginalAP
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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