Bentyl, Bentyl Preservative Free

NDA 8370, held by Abbvie. Dicyclomine Hydrochloride.

As of Nov 13, 2026, NDA 8370 (Bentyl, Bentyl Preservative Free), held by Abbvie, was first approved by FDA on Aug 13, 1952, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1952
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Aug 13, 1952	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Bentyl10MG/ML · injectable;injection	Dicyclomine Hydrochloride	DiscontinuedReference drug
Bentyl Preservative Free10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dicyclomine Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Jan 11, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 1, 2011	Supplement 32Labeling	Approved	Letter Label
Feb 2, 2007	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 12, 2002	Supplement 30Labeling · Standard review	Approved	Letter
Jun 23, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 28Labeling · Standard review	Approved	None posted
Sep 6, 1996	Supplement 27Labeling · Standard review	Approved	None posted
Jan 4, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 23, 1991	Supplement 26Labeling	Approved	None posted
Mar 18, 1991	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 25, 1990	Supplement 24Labeling	Approved	None posted
Aug 4, 1989	Supplement 13Labeling	Approved	None posted
Feb 18, 1988	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 6, 1987	Supplement 21Labeling	Approved	None posted
Jun 12, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
May 13, 1985	Supplement 19Labeling	Approved	None posted
Oct 15, 1984	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 15, 1984	Supplement 17Labeling	Approved	None posted
Aug 13, 1952	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 8370
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters