APPLICATION
ANDA040169
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-24
LATEST ACTION
2017-12-27
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 10MG/5ML · SYRUP · ORAL
Approval history
2017-12-27Labeling · Supplement 4 · standardAP
2008-08-28Labeling · Supplement 2AP
2005-03-24OriginalAP
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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