APPLICATION
NDA010996
TYPE
NDA
ORIGINAL APPROVAL
1957-11-12
LATEST ACTION
2004-05-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DARVON COMPOUND-65Discontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL
DARVON W/ ASADiscontinued
ASPIRIN 325MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL
DARVON COMPOUNDDiscontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 32MG · CAPSULE · ORAL
Approval history
1999-02-24Manufacturing (CMC) · Supplement 65 · priorityAP
1998-10-05Manufacturing (CMC) · Supplement 64 · priorityAP
1998-08-10Manufacturing (CMC) · Supplement 63 · priorityAP
1998-04-06Manufacturing (CMC) · Supplement 62 · priorityAP
1994-09-02Labeling · Supplement 58 · priorityAP
1994-08-23Labeling · Supplement 55 · priorityAP
1992-09-15Manufacturing (CMC) · Supplement 57 · priorityAP
1992-09-15Manufacturing (CMC) · Supplement 60 · priorityAP
1987-04-16Manufacturing (CMC) · Supplement 48 · priorityAP
1986-12-16Manufacturing (CMC) · Supplement 47 · priorityAP
1986-09-02Manufacturing (CMC) · Supplement 41 · priorityAP
1986-07-16Labeling · Supplement 42 · priorityAP
1986-04-21Labeling · Supplement 40 · priorityAP
1986-04-21Labeling · Supplement 37 · priorityAP
1985-01-28Manufacturing (CMC) · Supplement 36 · priorityAP
1983-03-08Manufacturing (CMC) · Supplement 35 · priorityAP
1981-10-28Labeling · Supplement 34 · priorityAP
1981-10-28Labeling · Supplement 33 · priorityAP
1981-05-20Labeling · Supplement 32 · priorityAP
1980-04-16Labeling · Supplement 31 · priorityAP
1980-01-18Manufacturing (CMC) · Supplement 24 · priorityAP
1979-09-26Labeling · Supplement 30 · priorityAP
1979-07-17Labeling · Supplement 29 · priorityAP
1979-03-26Labeling · Supplement 28 · priorityAP
1978-10-13Manufacturing (CMC) · Supplement 27 · priorityAP
1978-05-26Manufacturing (CMC) · Supplement 26 · priorityAP
1977-05-03Manufacturing (CMC) · Supplement 22 · priorityAP
1977-05-03Manufacturing (CMC) · Supplement 23 · priorityAP
1976-07-23Labeling · Supplement 20 · priorityAP
1975-01-06Labeling · Supplement 14 · priorityAP
1957-11-12Type 4 - New Combination · 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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