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FDA ANDA · ANDA087893

SLO-BID

Sponsor: SANOFI AVENTIS US

APPLICATION
ANDA087893
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 200MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 38AP
1996-03-19Manufacturing (CMC) · Supplement 36AP
1991-12-16Manufacturing (CMC) · Supplement 29AP
1991-12-16Manufacturing (CMC) · Supplement 31AP
1991-12-16Manufacturing (CMC) · Supplement 28AP
1991-12-16Manufacturing (CMC) · Supplement 30AP
1991-02-23Labeling · Supplement 33AP
1990-07-26Labeling · Supplement 32AP
1990-03-27Manufacturing (CMC) · Supplement 27AP
1990-03-27Manufacturing (CMC) · Supplement 25AP
1990-03-27Manufacturing (CMC) · Supplement 26AP
1989-06-07Manufacturing (CMC) · Supplement 24AP
1989-06-07Manufacturing (CMC) · Supplement 22AP
1988-01-19Manufacturing (CMC) · Supplement 15AP
1987-08-07Manufacturing (CMC) · Supplement 17AP
1986-12-31Manufacturing (CMC) · Supplement 6AP
1986-12-31Manufacturing (CMC) · Supplement 11AP
1986-12-31Manufacturing (CMC) · Supplement 12AP
1986-07-09Manufacturing (CMC) · Supplement 9AP
1985-07-23Manufacturing (CMC) · Supplement 8AP
1985-06-24Manufacturing (CMC) · Supplement 7AP
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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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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