APPLICATION
NDA008306
TYPE
NDA
ORIGINAL APPROVAL
1952-01-21
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PHENERGAN W/ CODEINE · ReferenceDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
PHENERGAN VC W/ CODEINE · ReferenceDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
2000-06-23Manufacturing (CMC) · Supplement 27 · standardAP
1998-05-06Manufacturing (CMC) · Supplement 25 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 24 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 22 · standardAP
1989-12-12Manufacturing (CMC) · Supplement 20 · standardAP
1989-12-12Manufacturing (CMC) · Supplement 21 · standardAP
1989-01-11Labeling · Supplement 19AP
1988-06-30Manufacturing (CMC) · Supplement 18 · standardAP
1987-04-13Manufacturing (CMC) · Supplement 14 · standardAP
1986-05-29Manufacturing (CMC) · Supplement 13 · standardAP
1985-11-04Labeling · Supplement 16AP
1985-07-29Manufacturing (CMC) · Supplement 15 · standardAP
1984-04-12Labeling · Supplement 12AP
1984-04-02Manufacturing (CMC) · Supplement 10 · standardAP
1984-04-02Efficacy · Supplement 11AP
1952-01-21Type 4 - New Combination · Original · 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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