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FDA ANDA · ANDA089959
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor: SANDOZ
APPLICATION
ANDA089959
TYPE
ANDA
ORIGINAL APPROVAL
1989-07-18
LATEST ACTION
2001-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE HYDROCHLORIDE 65MG · TABLET · ORAL
Approval history
2001-01-08Manufacturing (CMC) · Supplement 8AP
1998-05-11Manufacturing (CMC) · Supplement 6AP
1996-09-25Manufacturing (CMC) · Supplement 7AP
1993-06-28Labeling · Supplement 5AP
1992-04-07Manufacturing (CMC) · Supplement 3AP
1991-05-17Labeling · Supplement 4AP
1990-08-22Manufacturing (CMC) · Supplement 2AP
1989-10-26Labeling · Supplement 1AP
1989-07-18OriginalAP
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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