Dicyclomine Hydrochloride

ANDA 84600, held by Sun Pharm Industries. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 84600 (Dicyclomine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on May 20, 1975, with 13 approved supplements and 0 published complete response letters.

First approved: May 20, 1975
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
May 20, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicyclomine Hydrochloride20MG · tablet;oral	Dicyclomine Hydrochloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 47Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 46Labeling	Approved	None posted
Dec 23, 1994	Supplement 45Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 44Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 41Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 43Manufacturing	Approved	None posted
May 1, 1991	Supplement 38Manufacturing	Approved	None posted
Jan 11, 1991	Supplement 40Labeling	Approved	None posted
Aug 24, 1990	Supplement 37Labeling	Approved	None posted
Jun 1, 1989	Supplement 36Labeling	Approved	None posted
Mar 20, 1987	Supplement 34Manufacturing	Approved	None posted
Jul 25, 1985	Supplement 31Manufacturing	Approved	None posted
Jul 25, 1985	Supplement 32Manufacturing	Approved	None posted
May 20, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84600
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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