APPLICATION
ANDA085328
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-12
LATEST ACTION
2002-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEO-DUR · ReferenceDiscontinued
THEOPHYLLINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
THEO-DUR · ReferenceDiscontinued
THEOPHYLLINE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2002-01-10Labeling · Supplement 48AP
2001-01-05Manufacturing (CMC) · Supplement 46AP
1998-09-08Manufacturing (CMC) · Supplement 44AP
1997-08-18Labeling · Supplement 42AP
1997-08-18Labeling · Supplement 43AP
1996-07-17Labeling · Supplement 41AP
1989-10-26Labeling · Supplement 37AP
1988-06-22Manufacturing (CMC) · Supplement 38AP
1988-06-22Manufacturing (CMC) · Supplement 39AP
1986-12-18Manufacturing (CMC) · Supplement 36AP
1986-09-18Manufacturing (CMC) · Supplement 34AP
1986-09-18Manufacturing (CMC) · Supplement 35AP
1986-09-18Manufacturing (CMC) · Supplement 33AP
1986-07-16Manufacturing (CMC) · Supplement 32AP
1986-03-14Manufacturing (CMC) · Supplement 30AP
1986-03-14Manufacturing (CMC) · Supplement 29AP
1986-03-14Manufacturing (CMC) · Supplement 31AP
1986-02-14Manufacturing (CMC) · Supplement 28AP
1985-06-04Manufacturing (CMC) · Supplement 25AP
1985-02-21Manufacturing (CMC) · Supplement 23AP
1985-02-20Manufacturing (CMC) · Supplement 24AP
1984-01-03Manufacturing (CMC) · Supplement 21AP
1983-01-11Manufacturing (CMC) · Supplement 15AP
1979-04-12OriginalAP
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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