APPLICATION
ANDA040500
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-30
LATEST ACTION
2005-06-09
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 12.5MG · SUPPOSITORY · RECTAL
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 25MG · SUPPOSITORY · RECTAL
Approval history
2005-06-09Labeling · Supplement 3AP
2003-06-30OriginalAP
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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