FDA NDA · NDA020606

IMODIUM MULTI-SYMPTOM RELIEF

Sponsor: J AND J CONSUMER INC

APPLICATION

NDA020606

TYPE

NDA

ORIGINAL APPROVAL

1997-06-26

LATEST ACTION

2017-04-12

ROUTE

ORAL

DOSAGE FORM

TABLET, CHEWABLE

MARKETING STATUS

Discontinued

Products

IMODIUM MULTI-SYMPTOM RELIEF · ReferenceDiscontinued

LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG · TABLET, CHEWABLE · ORAL

2017-04-12Labeling · Supplement 17 · standard — Label ↗AP

2008-04-30Efficacy · Supplement 14 · unknown — Summary Review ↗AP

2004-06-16Labeling · Supplement 9 · standard — Review ↗AP

2001-06-21Manufacturing (CMC) · Supplement 8 · standardAP

1999-12-03Manufacturing (CMC) · Supplement 6 · standardAP

1999-11-29Manufacturing (CMC) · Supplement 7 · standardAP

1999-10-04Manufacturing (CMC) · Supplement 5 · standardAP

1998-10-14Manufacturing (CMC) · Supplement 4 · standardAP

1998-09-10Manufacturing (CMC) · Supplement 1 · standardAP

1998-09-04Manufacturing (CMC) · Supplement 2 · standardAP

1997-06-26Type 4 - New Combination · Original · standard — Review ↗AP

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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