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FDA NDA · NDA007961

BENTYL

Sponsor: APTALIS PHARMA US

APPLICATION
NDA007961
TYPE
NDA
ORIGINAL APPROVAL
1951-04-30
LATEST ACTION
2011-08-01
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

BENTYL · ReferenceDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2011-08-01Labeling · Supplement 28 · unknown — Letter ↗AP
2007-02-02Labeling · Supplement 26 · standard — Letter ↗AP
1999-08-17Labeling · Supplement 25 · standardAP
1996-09-09Labeling · Supplement 24 · standardAP
1993-01-04Manufacturing (CMC) · Supplement 22 · standardAP
1990-09-25Labeling · Supplement 23AP
1989-08-04Labeling · Supplement 11AP
1987-02-06Labeling · Supplement 21AP
1985-06-12Manufacturing (CMC) · Supplement 20 · standardAP
1985-05-13Labeling · Supplement 19AP
1984-10-15Labeling · Supplement 16AP
1984-10-15Manufacturing (CMC) · Supplement 17 · standardAP
1951-04-30Type 3 - New Dosage Form · Original · standardAP
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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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