APPLICATION
ANDA086720
TYPE
ANDA
ORIGINAL APPROVAL
1980-06-25
LATEST ACTION
1996-03-01
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 80MG/15ML · ELIXIR · ORAL
Approval history
1996-03-01Labeling · Supplement 11AP
1990-03-26Labeling · Supplement 10AP
1988-07-15Labeling · Supplement 7AP
1983-07-18Manufacturing (CMC) · Supplement 3AP
1980-06-25OriginalAP
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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