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FDA ANDA · ANDA040034

THEOPHYLLINE

Sponsor: INWOOD LABS

APPLICATION
ANDA040034
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2002-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

THEOPHYLLINEDiscontinued
THEOPHYLLINE 450MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-02-12Manufacturing (CMC) · Supplement 4AP
1998-01-28Manufacturing (CMC) · Supplement 3AP
1997-02-07Labeling · Supplement 2AP
1996-10-17Labeling · Supplement 1AP
1995-04-28OriginalAP
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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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