APPLICATION
ANDA086024
TYPE
ANDA
ORIGINAL APPROVAL
1979-01-08
LATEST ACTION
2018-01-29
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CAPITAL AND CODEINEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SUSPENSION · ORAL
Approval history
2018-01-29Labeling · Supplement 21 · standardAP
2017-08-29Labeling · Supplement 20 · standardAP
2017-08-29Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 17 · standardAP
2014-07-24Labeling · Supplement 16 · standardAP
2014-07-24Labeling · Supplement 15 · standardAP
2011-09-15Labeling · Supplement 14AP
2008-05-16Labeling · Supplement 13AP
2007-12-07Labeling · Supplement 12AP
2004-03-08Labeling · Supplement 10AP
2003-10-23Labeling · Supplement 11AP
1990-11-14Labeling · Supplement 8AP
1989-07-20Labeling · Supplement 7AP
1979-01-08OriginalAP
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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