APPLICATION
ANDA074911
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-22
LATEST ACTION
2016-01-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHRENILIN WITH CAFFEINE AND CODEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL
Approval history
2016-01-21Labeling · Supplement 9 · standardAP
2008-02-28Labeling · Supplement 8AP
2007-11-30Labeling · Supplement 7AP
2003-03-05Labeling · Supplement 2AP
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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