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FDA ANDA · ANDA088253

T-PHYL

Sponsor: PHARM RES ASSOC

APPLICATION
ANDA088253
TYPE
ANDA
ORIGINAL APPROVAL
1983-08-17
LATEST ACTION
2002-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

T-PHYLDiscontinued
THEOPHYLLINE 200MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-07-18Labeling · Supplement 22AP
2000-08-29Manufacturing (CMC) · Supplement 19AP
2000-08-29Manufacturing (CMC) · Supplement 17AP
2000-08-29Manufacturing (CMC) · Supplement 21AP
2000-08-29Manufacturing (CMC) · Supplement 18AP
2000-08-29Manufacturing (CMC) · Supplement 16AP
2000-08-29Manufacturing (CMC) · Supplement 20AP
1996-08-28Labeling · Supplement 15AP
1995-01-12Manufacturing (CMC) · Supplement 12AP
1992-02-11Labeling · Supplement 6AP
1992-02-11Labeling · Supplement 7AP
1990-03-08Bioequivalence · Supplement 9AP
1983-08-17OriginalAP
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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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