APPLICATION
ANDA083712
TYPE
ANDA
ORIGINAL APPROVAL
1973-09-21
LATEST ACTION
1989-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
1989-09-28Labeling · Supplement 30AP
1988-07-15Labeling · Supplement 28AP
1973-09-21OriginalAP
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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