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FDA ANDA · ANDA088269

SLO-BID

Sponsor: SANOFI AVENTIS US

APPLICATION
ANDA088269
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-31
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SLO-BIDDiscontinued
THEOPHYLLINE 50MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 34AP
1996-03-19Manufacturing (CMC) · Supplement 32AP
1990-11-20Labeling · Supplement 29AP
1990-06-21Labeling · Supplement 28AP
1990-03-27Manufacturing (CMC) · Supplement 26AP
1990-03-27Manufacturing (CMC) · Supplement 25AP
1989-06-07Labeling · Supplement 21AP
1989-06-07Manufacturing (CMC) · Supplement 22AP
1989-06-07Manufacturing (CMC) · Supplement 20AP
1988-10-04Labeling · Supplement 24AP
1988-05-13Manufacturing (CMC) · Supplement 9AP
1988-03-30Manufacturing (CMC) · Supplement 17AP
1988-01-19Manufacturing (CMC) · Supplement 16AP
1988-01-19Manufacturing (CMC) · Supplement 19AP
1987-08-07Manufacturing (CMC) · Supplement 15AP
1986-04-08Manufacturing (CMC) · Supplement 11AP
1985-04-18Manufacturing (CMC) · Supplement 4AP
1985-04-18Manufacturing (CMC) · Supplement 2AP
1985-04-18Manufacturing (CMC) · Supplement 3AP
1985-04-18Manufacturing (CMC) · Supplement 1AP
1985-01-31OriginalAP
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