APPLICATION
ANDA084285
TYPE
ANDA
ORIGINAL APPROVAL
1974-09-30
LATEST ACTION
2013-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2013-04-30Labeling · Supplement 15 · standardAP
2011-09-30Labeling · Supplement 14AP
2008-02-29Labeling · Supplement 12AP
2008-02-29Labeling · Supplement 13AP
2007-09-07Labeling · Supplement 11AP
2000-08-10Manufacturing (CMC) · Supplement 8AP
1998-08-07Manufacturing (CMC) · Supplement 7AP
1998-03-25Labeling · Supplement 6AP
1996-10-03Labeling · Supplement 4AP
1996-04-17Labeling · Supplement 3AP
1996-03-15Manufacturing (CMC) · Supplement 2AP
1974-09-30OriginalAP
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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