APPLICATION
ANDA087727
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-16
LATEST ACTION
2000-11-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
AMINOPHYLLINE DYE FREEDiscontinued
AMINOPHYLLINE 105MG/5ML · SOLUTION · ORAL
Approval history
2000-11-13Manufacturing (CMC) · Supplement 19AP
1997-09-05Labeling · Supplement 17AP
1996-07-26Labeling · Supplement 16AP
1993-12-03Manufacturing (CMC) · Supplement 15AP
1991-03-05Manufacturing (CMC) · Supplement 13AP
1990-09-28Manufacturing (CMC) · Supplement 14AP
1990-05-16Manufacturing (CMC) · Supplement 11AP
1990-04-04Labeling · Supplement 12AP
1989-12-19Labeling · Supplement 10AP
1989-11-06Labeling · Supplement 4AP
1989-10-02Labeling · Supplement 9AP
1989-05-31Manufacturing (CMC) · Supplement 8AP
1988-05-09Labeling · Supplement 7AP
1987-08-14Manufacturing (CMC) · Supplement 6AP
1987-08-14Manufacturing (CMC) · Supplement 5AP
1986-04-17Manufacturing (CMC) · Supplement 3AP
1983-05-17Manufacturing (CMC) · Supplement 2AP
1982-04-16OriginalAP
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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