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FDA NDA · NDA008370

BENTYL

Sponsor: ABBVIE

APPLICATION
NDA008370
TYPE
NDA
ORIGINAL APPROVAL
1952-08-13
LATEST ACTION
2013-01-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BENTYL · ReferenceDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
BENTYL PRESERVATIVE FREE · ReferenceDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2013-01-11Labeling · Supplement 33 · standard — Label ↗AP
2011-08-01Labeling · Supplement 32 · unknown — Letter ↗AP
2007-02-02Labeling · Supplement 31 · standard — Letter ↗AP
2002-08-12Labeling · Supplement 30 · standard — Letter ↗AP
2000-06-23Manufacturing (CMC) · Supplement 29 · standardAP
1999-08-17Labeling · Supplement 28 · standardAP
1996-09-06Labeling · Supplement 27 · standardAP
1993-01-04Manufacturing (CMC) · Supplement 23 · standardAP
1991-12-23Labeling · Supplement 26AP
1991-03-18Manufacturing (CMC) · Supplement 25 · standardAP
1990-09-25Labeling · Supplement 24AP
1989-08-04Labeling · Supplement 13AP
1988-02-18Manufacturing (CMC) · Supplement 22 · standardAP
1987-02-06Labeling · Supplement 21AP
1985-06-12Manufacturing (CMC) · Supplement 20 · standardAP
1985-05-13Labeling · Supplement 19AP
1984-10-15Labeling · Supplement 17AP
1984-10-15Manufacturing (CMC) · Supplement 18 · standardAP
1952-08-13Type 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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