APPLICATION
ANDA086748
TYPE
ANDA
ORIGINAL APPROVAL
1980-01-30
LATEST ACTION
1997-01-28
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 80MG/15ML · ELIXIR · ORAL
Approval history
1997-01-28Labeling · Supplement 32AP
1995-08-22Labeling · Supplement 31AP
1995-02-22Labeling · Supplement 30AP
1990-06-04Labeling · Supplement 29AP
1989-06-08Manufacturing (CMC) · Supplement 27AP
1989-04-26Labeling · Supplement 28AP
1988-07-21Manufacturing (CMC) · Supplement 26AP
1987-03-30Manufacturing (CMC) · Supplement 21AP
1985-11-27Manufacturing (CMC) · Supplement 16AP
1985-11-27Manufacturing (CMC) · Supplement 15AP
1982-09-08Manufacturing (CMC) · Supplement 11AP
1982-09-08Manufacturing (CMC) · Supplement 12AP
1982-08-30Manufacturing (CMC) · Supplement 13AP
1980-01-30OriginalAP
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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