Dicyclomine Hydrochloride

ANDA 80614, held by Dr Reddys. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 80614 (Dicyclomine Hydrochloride), held by Dr Reddys, was first approved by FDA on Feb 11, 1986, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1986
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 11, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicyclomine Hydrochloride10MG/ML · injectable;injection	Dicyclomine Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 43Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 42Manufacturing	Approved	None posted
Mar 25, 1998	Supplement 39Labeling	Approved	None posted
Aug 28, 1996	Supplement 37Manufacturing	Approved	None posted
Jul 23, 1991	Supplement 36Labeling	Approved	None posted
Nov 14, 1990	Supplement 35Labeling	Approved	None posted
Nov 15, 1988	Supplement 33Manufacturing	Approved	None posted
Jul 14, 1988	Supplement 32Labeling	Approved	None posted
Jun 16, 1986	Supplement 30Manufacturing	Approved	None posted
Feb 11, 1986	Original application	Approved	None posted
Jan 11, 1985	Supplement 29Manufacturing	Approved	None posted
Feb 22, 1984	Supplement 27Manufacturing	Approved	None posted

Identifiers

Application: ANDA 80614
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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