Clonidine Hydrochloride

Treats hypertension. ANDA 91368, held by Alembic Pharms Ltd. Clonidine Hydrochloride.

As of Nov 15, 2026, ANDA 91368 (Clonidine Hydrochloride), held by Alembic Pharms Ltd, was first approved by FDA on Dec 6, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 6, 2011	Original application	Approved	None posted

Products

4 strengths and forms


Clonidine Hydrochloride0.1MG · tablet;oral	Clonidine Hydrochloride	Rx
Clonidine Hydrochloride0.2MG · tablet;oral	Clonidine Hydrochloride	Rx
Clonidine Hydrochloride0.3MG · tablet;oral	Clonidine Hydrochloride	Rx
Clonidine Hydrochloride0.05MG · tablet;oral	Clonidine Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 17, 2026	Supplement 24Manufacturing	Approved	None posted
Jan 17, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Dec 6, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91368
Drugs@FDA: Overview at FDA
Company: Alembic Pharmaceuticals

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