APPLICATION
ANDA088704
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-22
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
TRIACIN-CPrescription
CODEINE PHOSPHATE 10MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML, TRIPROLIDINE HYDROCHLORIDE 1.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-22Labeling · Supplement 40 · standardAP
2023-12-15Labeling · Supplement 39 · standardAP
2018-06-28Labeling · Supplement 38 · standardAP
2017-08-29Labeling · Supplement 37 · standardAP
2017-03-15Labeling · Supplement 36 · standardAP
2017-03-15Labeling · Supplement 35 · standardAP
2017-01-13Labeling · Supplement 34 · standardAP
2015-07-08Labeling · Supplement 33 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 21AP
1998-08-19Manufacturing (CMC) · Supplement 20AP
1995-03-31Manufacturing (CMC) · Supplement 18AP
1994-06-06Manufacturing (CMC) · Supplement 17AP
1992-09-11Labeling · Supplement 13AP
1992-06-05Manufacturing (CMC) · Supplement 11AP
1992-01-08Labeling · Supplement 16AP
1990-09-28Manufacturing (CMC) · Supplement 12AP
1990-05-01Labeling · Supplement 10AP
1989-06-07Manufacturing (CMC) · Supplement 7AP
1989-06-07Manufacturing (CMC) · Supplement 6AP
1987-03-17Manufacturing (CMC) · Supplement 5AP
1986-12-11Manufacturing (CMC) · Supplement 3AP
1986-12-11Manufacturing (CMC) · Supplement 4AP
1985-12-06Manufacturing (CMC) · Supplement 1AP
1985-12-06Manufacturing (CMC) · 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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