APPLICATION
ANDA088831
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-19
LATEST ACTION
2002-05-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHRENILIN FORTEDiscontinued
ACETAMINOPHEN 650MG, BUTALBITAL 50MG · CAPSULE · ORAL
Approval history
2002-05-08Manufacturing (CMC) · Supplement 29AP
2002-02-19Manufacturing (CMC) · Supplement 28AP
2001-12-06Manufacturing (CMC) · Supplement 27AP
2001-08-16Manufacturing (CMC) · Supplement 26AP
2000-09-27Manufacturing (CMC) · Supplement 22AP
2000-09-27Manufacturing (CMC) · Supplement 25AP
2000-09-27Labeling · Supplement 23AP
2000-09-27Manufacturing (CMC) · Supplement 21AP
2000-05-09Manufacturing (CMC) · Supplement 24AP
1997-04-28Manufacturing (CMC) · Supplement 18AP
1997-04-28Labeling · Supplement 19AP
1997-01-21Manufacturing (CMC) · Supplement 17AP
1996-04-17Manufacturing (CMC) · Supplement 20AP
1994-09-29Manufacturing (CMC) · Supplement 16AP
1994-06-10Labeling · Supplement 15AP
1993-12-07Labeling · Supplement 14AP
1992-07-01Labeling · Supplement 11AP
1992-05-08Labeling · Supplement 13AP
1992-01-02Manufacturing (CMC) · Supplement 8AP
1991-03-28Manufacturing (CMC) · Supplement 9AP
1991-03-28Manufacturing (CMC) · Supplement 7AP
1991-03-28Manufacturing (CMC) · Supplement 10AP
1991-03-28Manufacturing (CMC) · Supplement 1AP
1989-04-12Manufacturing (CMC) · Supplement 5AP
1989-04-12Manufacturing (CMC) · Supplement 3AP
1989-04-12Manufacturing (CMC) · Supplement 6AP
1989-04-12Manufacturing (CMC) · Supplement 2AP
1988-11-17Labeling · Supplement 4AP
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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