APPLICATION
ANDA084772
TYPE
ANDA
ORIGINAL APPROVAL
1978-11-14
LATEST ACTION
1990-04-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETH FORTISDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG/5ML · SYRUP · ORAL
Approval history
1990-04-18Labeling · Supplement 20AP
1989-11-28Labeling · Supplement 19AP
1988-09-27Labeling · Supplement 16AP
1988-06-06Labeling · Supplement 15AP
1978-11-14OriginalAP
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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