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FDA ANDA · ANDA086998

THEO-DUR

Sponsor: SCHERING

APPLICATION
ANDA086998
TYPE
ANDA
ORIGINAL APPROVAL
1980-01-31
LATEST ACTION
2002-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

THEO-DUR · ReferenceDiscontinued
THEOPHYLLINE 200MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-01-10Labeling · Supplement 38AP
1997-08-18Labeling · Supplement 35AP
1997-08-18Labeling · Supplement 34AP
1996-07-17Labeling · Supplement 33AP
1989-10-26Labeling · Supplement 29AP
1988-06-22Manufacturing (CMC) · Supplement 31AP
1988-06-22Manufacturing (CMC) · Supplement 30AP
1986-12-18Manufacturing (CMC) · Supplement 27AP
1986-03-14Manufacturing (CMC) · Supplement 25AP
1986-03-14Manufacturing (CMC) · Supplement 23AP
1986-03-14Manufacturing (CMC) · Supplement 24AP
1986-02-18Manufacturing (CMC) · Supplement 22AP
1985-09-20Manufacturing (CMC) · Supplement 18AP
1984-01-03Manufacturing (CMC) · Supplement 16AP
1983-07-18Manufacturing (CMC) · Supplement 12AP
1983-01-12Manufacturing (CMC) · Supplement 9AP
1983-01-12Manufacturing (CMC) · Supplement 8AP
1980-01-31OriginalAP
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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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