FDA NDA · NDA020448

IMODIUM A-D EZ CHEWS

Sponsor: J AND J CONSUMER INC

APPLICATION

NDA020448

TYPE

NDA

ORIGINAL APPROVAL

1997-07-24

LATEST ACTION

2017-04-12

ROUTE

ORAL

DOSAGE FORM

TABLET, CHEWABLE

MARKETING STATUS

Discontinued

Products

IMODIUM A-D EZ CHEWS · ReferenceDiscontinued

LOPERAMIDE HYDROCHLORIDE 2MG · TABLET, CHEWABLE · ORAL

2017-04-12Labeling · Supplement 11 · standard — Label ↗AP

2014-05-22Manufacturing (CMC) · Supplement 9 · standardAP

2014-03-20Manufacturing (CMC) · Supplement 8 · standardAP

2013-09-27Manufacturing (CMC) · Supplement 7 · standardAP

2007-01-11Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP

1998-09-10Manufacturing (CMC) · Supplement 2 · standardAP

1998-09-04Manufacturing (CMC) · Supplement 1 · standardAP

1997-07-24Type 3 - New Dosage Form · 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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