APPLICATION
ANDA088811
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-07
LATEST ACTION
2016-06-03
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
BROMFED-DM · ReferenceDiscontinued
BROMPHENIRAMINE MALEATE 2MG/5ML, DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML · SYRUP · ORAL
Approval history
2016-06-03Labeling · Supplement 26 · standardAP
2016-06-03Labeling · Supplement 18AP
2016-06-03Manufacturing (CMC) · Supplement 19AP
2004-09-30Labeling · Supplement 13AP
1999-01-12Labeling · Supplement 10AP
1994-03-04Labeling · Supplement 9AP
1991-08-19Labeling · Supplement 8AP
1989-05-10Labeling · Supplement 6AP
1989-04-05Manufacturing (CMC) · Supplement 5AP
1988-08-17Manufacturing (CMC) · Supplement 4AP
1987-05-15Manufacturing (CMC) · Supplement 3AP
1987-05-15Manufacturing (CMC) · Supplement 2AP
1986-08-08Manufacturing (CMC) · Supplement 1AP
1985-06-07OriginalAP
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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