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FDA ANDA · ANDA084445

PHENAPHEN W/ CODEINE NO. 3

Sponsor: ROBINS AH

APPLICATION
ANDA084445
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. 3 · ReferenceDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL

Approval history

1998-04-07Manufacturing (CMC) · Supplement 61AP
1994-01-21Manufacturing (CMC) · Supplement 58AP
1991-12-11Labeling · Supplement 59AP
1991-02-05Manufacturing (CMC) · Supplement 46AP
1989-05-08Labeling · Supplement 57AP
1988-11-15Manufacturing (CMC) · Supplement 48AP
1988-05-04Labeling · Supplement 56AP
1987-11-25Manufacturing (CMC) · Supplement 54AP
1987-11-25Manufacturing (CMC) · Supplement 52AP
1987-11-25Manufacturing (CMC) · Supplement 49AP
1987-11-25Manufacturing (CMC) · Supplement 53AP
1985-09-18Manufacturing (CMC) · Supplement 42AP
1985-09-18Manufacturing (CMC) · Supplement 40AP
1985-09-18Manufacturing (CMC) · Supplement 43AP
1985-09-18Manufacturing (CMC) · Supplement 41AP
1982-07-28Manufacturing (CMC) · Supplement 37AP
1982-07-27Manufacturing (CMC) · Supplement 38AP
1982-07-27Manufacturing (CMC) · Supplement 36AP
1975-07-22OriginalAP
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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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