APPLICATION
ANDA073243
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-21
LATEST ACTION
2007-09-06
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LOPERAMIDE HYDROCHLORIDEDiscontinued
LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SOLUTION · ORAL
Approval history
2007-09-06Labeling · Supplement 31AP
2001-11-26Labeling · Supplement 12AP
1999-06-29Labeling · Supplement 9AP
1999-06-29Manufacturing (CMC) · Supplement 10AP
1996-04-17Manufacturing (CMC) · Supplement 6AP
1996-03-25Labeling · Supplement 7AP
1996-03-25Labeling · Supplement 5AP
1994-06-20Manufacturing (CMC) · Supplement 3AP
1994-06-02Labeling · Supplement 4AP
1993-08-30Manufacturing (CMC) · Supplement 2AP
1992-01-21OriginalAP
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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