APPLICATION
NDA017122
TYPE
NDA
ORIGINAL APPROVAL
1972-12-19
LATEST ACTION
2009-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DARVOCET-N 50Discontinued
ACETAMINOPHEN 325MG, PROPOXYPHENE NAPSYLATE 50MG · TABLET · ORAL
DARVOCET-N 100Discontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE NAPSYLATE 100MG · TABLET · ORAL
Approval history
2007-01-24Manufacturing (CMC) · Supplement 59 · standardAP
2006-05-11Manufacturing (CMC) · Supplement 58 · standardAP
2005-07-13Manufacturing (CMC) · Supplement 57 · standardAP
2005-04-12Manufacturing (CMC) · Supplement 56 · standardAP
2005-02-03Manufacturing (CMC) · Supplement 54 · standardAP
2005-02-03Manufacturing (CMC) · Supplement 55 · standardAP
2001-10-30Labeling · Supplement 46 · standardAP
2001-10-30Labeling · Supplement 47 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 53 · standardAP
1998-10-05Manufacturing (CMC) · Supplement 52 · standardAP
1998-08-10Manufacturing (CMC) · Supplement 51 · standardAP
1998-04-02Manufacturing (CMC) · Supplement 50 · standardAP
1997-05-15Manufacturing (CMC) · Supplement 48 · standardAP
1995-03-20Labeling · Supplement 39 · standardAP
1995-03-14Manufacturing (CMC) · Supplement 45 · standardAP
1994-09-02Labeling · Supplement 43 · standardAP
1994-08-23Labeling · Supplement 40 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 44 · standardAP
1993-12-17Manufacturing (CMC) · Supplement 41 · standardAP
1992-09-15Manufacturing (CMC) · Supplement 42 · standardAP
1987-04-16Manufacturing (CMC) · Supplement 34 · standardAP
1986-10-17Labeling · Supplement 30 · standardAP
1986-04-21Labeling · Supplement 29 · standardAP
1986-04-03Labeling · Supplement 28 · standardAP
1984-08-16Manufacturing (CMC) · Supplement 25 · standardAP
1984-08-07Labeling · Supplement 24 · standardAP
1981-10-28Labeling · Supplement 23 · standardAP
1981-05-20Labeling · Supplement 22 · standardAP
1980-04-16Labeling · Supplement 21 · standardAP
1980-01-21Manufacturing (CMC) · Supplement 14 · standardAP
1979-11-06Manufacturing (CMC) · Supplement 19 · standardAP
1979-09-26Labeling · Supplement 20 · standardAP
1979-07-17Labeling · Supplement 18 · standardAP
1979-06-29Manufacturing (CMC) · Supplement 16 · standardAP
1978-10-16Manufacturing (CMC) · Supplement 15 · standardAP
1977-06-10Labeling · Supplement 11 · standardAP
1977-05-06Manufacturing (CMC) · Supplement 13 · standardAP
1977-05-06Manufacturing (CMC) · Supplement 12 · standardAP
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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