APPLICATION
ANDA040161
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-01
LATEST ACTION
2015-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2015-03-05Labeling · Supplement 9 · standardAP
2012-05-11Labeling · Supplement 7AP
2002-01-17Manufacturing (CMC) · Supplement 5AP
2001-12-06Manufacturing (CMC) · Supplement 4AP
1998-10-01Manufacturing (CMC) · Supplement 3AP
1998-03-13Labeling · Supplement 2AP
1997-10-10Manufacturing (CMC) · Supplement 1AP
1996-10-01OriginalAP
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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