APPLICATION
ANDA089405
TYPE
ANDA
ORIGINAL APPROVAL
1990-05-15
LATEST ACTION
1996-11-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TENCONDiscontinued
ACETAMINOPHEN 650MG, BUTALBITAL 50MG · CAPSULE · ORAL
Approval history
1996-11-14Labeling · Supplement 9AP
1996-08-30Manufacturing (CMC) · Supplement 8AP
1994-09-29Manufacturing (CMC) · Supplement 7AP
1994-06-15Labeling · Supplement 6AP
1994-02-16Labeling · Supplement 5AP
1992-05-05Manufacturing (CMC) · Supplement 3AP
1992-04-16Labeling · Supplement 4AP
1991-05-20Labeling · Supplement 2AP
1990-05-15OriginalAP
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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