APPLICATION
ANDA087242
TYPE
ANDA
ORIGINAL APPROVAL
1983-10-26
LATEST ACTION
1999-07-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMINOPHYLLINE · ReferencePrescription
AMINOPHYLLINE 25MG/ML · INJECTABLE · INJECTION
Approval history
1999-07-30Manufacturing (CMC) · Supplement 16AP
1997-02-24Manufacturing (CMC) · Supplement 15AP
1996-12-31Labeling · Supplement 13AP
1996-10-03Manufacturing (CMC) · Supplement 14AP
1995-02-01Labeling · Supplement 5AP
1993-12-22Manufacturing (CMC) · Supplement 11AP
1992-08-28Manufacturing (CMC) · Supplement 10AP
1992-03-05Manufacturing (CMC) · Supplement 8AP
1992-03-05Manufacturing (CMC) · Supplement 6AP
1992-03-05Manufacturing (CMC) · Supplement 9AP
1992-03-05Manufacturing (CMC) · Supplement 7AP
1991-04-09Labeling · Supplement 3AP
1990-05-07Labeling · Supplement 4AP
1989-12-27Labeling · Supplement 2AP
1983-10-26OriginalAP
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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