APPLICATION
ANDA040449
TYPE
ANDA
ORIGINAL APPROVAL
2003-02-27
LATEST ACTION
2005-06-21
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 50MG · SUPPOSITORY · RECTAL
Approval history
2005-06-21Labeling · Supplement 3AP
2003-10-31Labeling · Supplement 1AP
2003-02-27OriginalAP
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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