APPLICATION
ANDA040204
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2012-05-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2012-05-11Labeling · Supplement 5AP
2002-01-22Manufacturing (CMC) · Supplement 3AP
1998-10-01Manufacturing (CMC) · Supplement 2AP
1997-09-17Labeling · Supplement 1AP
1997-02-28OriginalAP
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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