APPLICATION
ANDA040026
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-25
LATEST ACTION
2009-10-07
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDEPrescription
PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2009-10-07Labeling · Supplement 9AP
2007-03-22Labeling · Supplement 6AP
2006-06-12Labeling · Supplement 5AP
2006-04-03Labeling · Supplement 4AP
2005-07-27Labeling · Supplement 3AP
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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