APPLICATION
ANDA088816
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-22
LATEST ACTION
1996-10-23
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE VC W/ CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
1996-10-23Labeling · Supplement 7AP
1994-05-13Labeling · Supplement 6AP
1993-02-26Labeling · Supplement 2AP
1991-11-14Labeling · Supplement 3AP
1985-11-22OriginalAP
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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