APPLICATION
ANDA075028
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-20
LATEST ACTION
2017-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PENTOXIFYLLINEDiscontinued
PENTOXIFYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2017-02-02Labeling · Supplement 12 · standardAP
2017-02-02Labeling · Supplement 10 · standardAP
2017-02-02Labeling · Supplement 13 · standardAP
2006-12-07Labeling · Supplement 9AP
2002-02-20Manufacturing (CMC) · Supplement 6AP
2001-08-21Manufacturing (CMC) · Supplement 4AP
2001-08-21Manufacturing (CMC) · Supplement 5AP
2000-06-30Manufacturing (CMC) · Supplement 3AP
1999-06-11Manufacturing (CMC) · Supplement 2AP
1999-06-11Manufacturing (CMC) · Supplement 1AP
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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