APPLICATION
ANDA072195
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-16
LATEST ACTION
1998-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE NAPSYLATE 100MG · TABLET · ORAL
Approval history
1998-02-05Manufacturing (CMC) · Supplement 11AP
1993-12-22Manufacturing (CMC) · Supplement 10AP
1991-10-31Manufacturing (CMC) · Supplement 6AP
1991-10-31Labeling · Supplement 7AP
1990-03-07Labeling · Supplement 5AP
1990-01-31Manufacturing (CMC) · Supplement 4AP
1989-12-14Labeling · Supplement 2AP
1989-02-23Manufacturing (CMC) · Supplement 1AP
1989-01-30Manufacturing (CMC) · Supplement 3AP
1988-02-16OriginalAP
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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