APPLICATION
NDA010997
TYPE
NDA
ORIGINAL APPROVAL
1957-08-16
LATEST ACTION
2009-09-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DARVONDiscontinued
PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL
DARVONDiscontinued
PROPOXYPHENE HYDROCHLORIDE 32MG · CAPSULE · ORAL
Approval history
1999-02-24Manufacturing (CMC) · Supplement 47 · priorityAP
1998-10-05Manufacturing (CMC) · Supplement 46 · priorityAP
1998-08-10Manufacturing (CMC) · Supplement 45 · priorityAP
1998-04-02Manufacturing (CMC) · Supplement 44 · priorityAP
1994-09-02Labeling · Supplement 42 · priorityAP
1994-08-23Labeling · Supplement 40 · priorityAP
1992-09-15Manufacturing (CMC) · Supplement 41 · priorityAP
1986-12-08Manufacturing (CMC) · Supplement 35 · priorityAP
1986-11-05Manufacturing (CMC) · Supplement 32 · priorityAP
1986-10-16Labeling · Supplement 33 · priorityAP
1986-04-21Labeling · Supplement 27 · priorityAP
1986-04-21Labeling · Supplement 31 · priorityAP
1986-04-21Labeling · Supplement 28 · priorityAP
1985-01-28Manufacturing (CMC) · Supplement 26 · priorityAP
1981-10-28Labeling · Supplement 25 · priorityAP
1981-08-10Manufacturing (CMC) · Supplement 23 · priorityAP
1981-05-20Labeling · Supplement 24 · priorityAP
1980-04-15Labeling · Supplement 22 · priorityAP
1980-01-21Manufacturing (CMC) · Supplement 16 · priorityAP
1979-09-26Labeling · Supplement 21 · priorityAP
1979-02-27Manufacturing (CMC) · Supplement 18 · priorityAP
1978-10-13Manufacturing (CMC) · Supplement 20 · priorityAP
1978-05-26Manufacturing (CMC) · Supplement 19 · priorityAP
1977-05-03Manufacturing (CMC) · Supplement 15 · priorityAP
1977-05-03Manufacturing (CMC) · Supplement 14 · priorityAP
1976-07-23Labeling · Supplement 13 · priorityAP
1975-01-06Labeling · Supplement 10 · priorityAP
1957-08-16Type 1 - New Molecular Entity · Original · priorityAP
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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