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FDA ANDA · ANDA089018
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
Sponsor: CENCI
APPLICATION
ANDA089018
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-23
LATEST ACTION
1992-09-28
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML, TRIPROLIDINE HYDROCHLORIDE 1.25MG/5ML · SYRUP · ORAL
Approval history
1992-09-28Labeling · Supplement 3AP
1986-07-23OriginalAP
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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