Clonidine Hydrochloride

ANDA 210052, held by Amneal Pharms Ny. Clonidine Hydrochloride.

As of Nov 15, 2026, ANDA 210052 (Clonidine Hydrochloride), held by Amneal Pharms Ny, was first approved by FDA on Nov 20, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 20, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 20, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clonidine Hydrochloride0.1MG · tablet, extended release;oral	Clonidine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 29, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Nov 20, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 210052
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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