APPLICATION
ANDA085353
TYPE
ANDA
ORIGINAL APPROVAL
1980-08-11
LATEST ACTION
1980-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THEOCLEAR-100Discontinued
THEOPHYLLINE 100MG · TABLET · ORAL
THEOCLEAR-200Discontinued
THEOPHYLLINE 200MG · TABLET · ORAL
Approval history
1980-08-11OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.