APPLICATION
ANDA087449
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-15
LATEST ACTION
1999-02-01
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
THEOPHYLLINE · ReferenceDiscontinued
THEOPHYLLINE 80MG/15ML · SOLUTION · ORAL
Approval history
1999-02-01Manufacturing (CMC) · Supplement 13AP
1998-09-15Manufacturing (CMC) · Supplement 15AP
1996-09-20Labeling · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 10AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1990-11-09Labeling · Supplement 8AP
1988-03-24Manufacturing (CMC) · Supplement 6AP
1988-03-24Manufacturing (CMC) · Supplement 7AP
1986-07-10Manufacturing (CMC) · Supplement 1AP
1986-07-10Manufacturing (CMC) · Supplement 2AP
1983-09-15OriginalAP
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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