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FDA ANDA · ANDA073192

LOPERAMIDE HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA073192
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-30
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 28 · standardAP
2012-11-13Labeling · Supplement 24AP
2007-06-27Labeling · Supplement 22AP
2001-08-30Manufacturing (CMC) · Supplement 18AP
2000-07-07Manufacturing (CMC) · Supplement 17AP
1998-03-09Manufacturing (CMC) · Supplement 16AP
1997-10-09Manufacturing (CMC) · Supplement 15AP
1996-12-13Manufacturing (CMC) · Supplement 14AP
1995-10-03Manufacturing (CMC) · Supplement 12AP
1995-10-03Manufacturing (CMC) · Supplement 13AP
1995-10-03Manufacturing (CMC) · Supplement 11AP
1995-08-29Labeling · Supplement 10AP
1995-03-02Manufacturing (CMC) · Supplement 9AP
1994-01-26Manufacturing (CMC) · Supplement 7AP
1994-01-26Manufacturing (CMC) · Supplement 5AP
1994-01-26Manufacturing (CMC) · Supplement 3AP
1994-01-26Manufacturing (CMC) · Supplement 8AP
1994-01-26Manufacturing (CMC) · Supplement 6AP
1994-01-26Manufacturing (CMC) · Supplement 4AP
1994-01-13Manufacturing (CMC) · Supplement 1AP
1993-04-01Manufacturing (CMC) · Supplement 2AP
1992-04-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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