APPLICATION
ANDA088868
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-02
LATEST ACTION
1993-10-19
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PHERAZINE VCDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
1993-10-19Labeling · Supplement 3AP
1993-05-27Labeling · Supplement 2AP
1989-01-23Labeling · Supplement 1AP
1987-03-02OriginalAP
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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