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FDA ANDA · ANDA087501

AMINOPHYLLINE

Sponsor: ROXANE

APPLICATION
ANDA087501
TYPE
ANDA
ORIGINAL APPROVAL
1982-02-09
LATEST ACTION
1996-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 200MG · TABLET · ORAL

Approval history

1996-08-28Manufacturing (CMC) · Supplement 11AP
1996-08-15Labeling · Supplement 12AP
1995-09-11Manufacturing (CMC) · Supplement 10AP
1992-09-04Labeling · Supplement 9AP
1990-10-03Labeling · Supplement 8AP
1988-08-26Manufacturing (CMC) · Supplement 6AP
1988-08-26Manufacturing (CMC) · Supplement 5AP
1984-12-11Manufacturing (CMC) · Supplement 3AP
1982-02-09OriginalAP
VIEW ON DRUGS@FDA ↗

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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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