APPLICATION
ANDA084446
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-22
LATEST ACTION
1998-04-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENAPHEN W/ CODEINE NO. 4 · ReferenceDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 60MG · CAPSULE · ORAL
Approval history
1998-04-07Manufacturing (CMC) · Supplement 50AP
1991-12-11Labeling · Supplement 48AP
1991-05-06Manufacturing (CMC) · Supplement 40AP
1989-05-08Labeling · Supplement 47AP
1988-11-15Manufacturing (CMC) · Supplement 42AP
1988-05-04Labeling · Supplement 46AP
1987-11-25Manufacturing (CMC) · Supplement 43AP
1982-07-27Manufacturing (CMC) · Supplement 37AP
1982-07-27Manufacturing (CMC) · Supplement 36AP
1975-07-22OriginalAP
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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