APPLICATION
ANDA090468
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-14
LATEST ACTION
2017-11-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ZYFRELDiscontinued
ACETAMINOPHEN 325MG/15ML, HYDROCODONE BITARTRATE 7.5MG/15ML · SOLUTION · ORAL
Approval history
2017-11-28Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 2 · 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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