APPLICATION
ANDA072741
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-18
LATEST ACTION
2016-11-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LOPERAMIDE HYDROCHLORIDEPrescription
LOPERAMIDE HYDROCHLORIDE 2MG · CAPSULE · ORAL
Approval history
2016-11-03Labeling · Supplement 13 · standardAP
2007-06-25Labeling · Supplement 8AP
2000-08-02Manufacturing (CMC) · Supplement 6AP
1998-04-06Manufacturing (CMC) · Supplement 5AP
1998-04-06Manufacturing (CMC) · Supplement 3AP
1998-02-05Manufacturing (CMC) · Supplement 4AP
1996-04-18Labeling · Supplement 2AP
1991-09-18OriginalAP
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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