APPLICATION
ANDA040317
TYPE
ANDA
ORIGINAL APPROVAL
1999-09-07
LATEST ACTION
2013-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2013-04-30Labeling · Supplement 11 · standardAP
2012-12-28Labeling · Supplement 10 · standardAP
2007-11-30Labeling · Supplement 5AP
2002-12-12Manufacturing (CMC) · Supplement 2AP
1999-12-22Labeling · Supplement 1AP
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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