APPLICATION
ANDA088126
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-19
LATEST ACTION
1999-02-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 105MG/5ML · SOLUTION · ORAL
Approval history
1999-02-17Manufacturing (CMC) · Supplement 17AP
1999-02-17Manufacturing (CMC) · Supplement 13AP
1998-11-16Manufacturing (CMC) · Supplement 15AP
1998-08-31Labeling · Supplement 16AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1996-08-15Labeling · Supplement 12AP
1996-08-01Manufacturing (CMC) · Supplement 11AP
1992-08-26Labeling · Supplement 8AP
1990-10-03Labeling · Supplement 7AP
1990-04-06Manufacturing (CMC) · Supplement 5AP
1990-03-22Labeling · Supplement 6AP
1989-06-22Labeling · Supplement 2AP
1988-07-18Manufacturing (CMC) · Supplement 4AP
1988-07-18Manufacturing (CMC) · Supplement 3AP
1984-10-24Manufacturing (CMC) · Supplement 1AP
1983-08-19OriginalAP
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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