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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
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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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