APPLICATION
ANDA087811
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-19
LATEST ACTION
2014-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHRENILIN · ReferenceDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2014-12-13Labeling · Supplement 29 · standardAP
2011-08-10Labeling · Supplement 28AP
2003-06-03Labeling · Supplement 25AP
2001-12-06Manufacturing (CMC) · Supplement 23AP
2001-07-25Manufacturing (CMC) · Supplement 21AP
2001-07-25Manufacturing (CMC) · Supplement 22AP
1997-04-28Manufacturing (CMC) · Supplement 18AP
1997-04-28Labeling · Supplement 19AP
1996-04-26Manufacturing (CMC) · Supplement 20AP
1994-09-29Manufacturing (CMC) · Supplement 17AP
1994-06-10Labeling · Supplement 16AP
1993-12-07Labeling · Supplement 15AP
1992-08-04Manufacturing (CMC) · Supplement 12AP
1992-07-01Labeling · Supplement 11AP
1992-05-15Labeling · Supplement 14AP
1992-05-08Manufacturing (CMC) · Supplement 13AP
1992-03-27Manufacturing (CMC) · Supplement 10AP
1992-03-27Manufacturing (CMC) · Supplement 9AP
1989-10-05Manufacturing (CMC) · Supplement 8AP
1989-10-05Manufacturing (CMC) · Supplement 7AP
1989-04-07Manufacturing (CMC) · Supplement 5AP
1989-04-07Manufacturing (CMC) · Supplement 3AP
1989-04-07Manufacturing (CMC) · Supplement 6AP
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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