APPLICATION
NDA009319
TYPE
NDA
ORIGINAL APPROVAL
1954-04-28
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
AMBENYLDiscontinued
BROMODIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML, CODEINE PHOSPHATE 10MG/5ML · SYRUP · ORAL
Approval history
2007-12-07Labeling · Supplement 16AP
2007-12-07Labeling · Supplement 14AP
2007-12-07Labeling · Supplement 12AP
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 6AP
2007-12-07Labeling · Supplement 13AP
2007-12-07Labeling · Supplement 11AP
2007-12-07Labeling · Supplement 9AP
1993-11-10Labeling · Supplement 24AP
1993-04-14Manufacturing (CMC) · Supplement 28 · standardAP
1989-09-22Manufacturing (CMC) · Supplement 25 · standardAP
1988-08-26Manufacturing (CMC) · Supplement 23 · standardAP
1986-02-27Labeling · Supplement 21AP
1984-01-10Efficacy · Supplement 18AP
1984-01-10Manufacturing (CMC) · Supplement 17 · standardAP
1954-04-28Type 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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