APPLICATION
ANDA085075
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-24
LATEST ACTION
1990-10-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
AEROLATE IIIDiscontinued
THEOPHYLLINE 65MG · CAPSULE, EXTENDED RELEASE · ORAL
AEROLATE SRDiscontinued
THEOPHYLLINE 260MG · CAPSULE, EXTENDED RELEASE · ORAL
AEROLATE JRDiscontinued
THEOPHYLLINE 130MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1990-10-18Labeling · Supplement 4AP
1989-10-13Labeling · Supplement 2AP
1986-11-24OriginalAP
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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