APPLICATION
NDA007409
TYPE
NDA
ORIGINAL APPROVAL
1950-05-11
LATEST ACTION
2013-01-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Discontinued
Products
BENTYL · ReferenceDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
BENTYL · ReferenceDiscontinued
DICYCLOMINE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-08-17Labeling · Supplement 39 · standardAP
1996-09-09Labeling · Supplement 38 · standardAP
1993-01-04Manufacturing (CMC) · Supplement 33 · standardAP
1992-06-24Manufacturing (CMC) · Supplement 35 · standardAP
1991-10-29Manufacturing (CMC) · Supplement 36 · standardAP
1990-09-25Labeling · Supplement 34AP
1990-03-15Manufacturing (CMC) · Supplement 31 · standardAP
1989-08-04Labeling · Supplement 16AP
1989-06-15Manufacturing (CMC) · Supplement 32 · standardAP
1987-09-28Labeling · Supplement 26AP
1987-02-06Labeling · Supplement 29AP
1985-06-12Manufacturing (CMC) · Supplement 28 · standardAP
1985-05-13Labeling · Supplement 27AP
1984-10-15Manufacturing (CMC) · Supplement 25 · standardAP
1984-10-15Labeling · Supplement 24AP
1950-05-11Type 1 - New Molecular Entity · Original · standardAP
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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