Innopran Xl

Treats hypertension. NDA 21438, held by Ani Pharms. Propranolol Hydrochloride.

As of Nov 14, 2026, NDA 21438 (Innopran Xl), held by Ani Pharms, was first approved by FDA on Mar 12, 2003, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2003
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 12, 2003	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Review Letter

Products

2 strengths and forms


Innopran Xl80MG · capsule, extended release;oral	Propranolol Hydrochloride	RxReference drug
Innopran Xl120MG · capsule, extended release;oral	Propranolol Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Dec 22, 2023	Supplement 32Labeling · Standard review	Approved	Letter Label
Aug 16, 2021	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 19, 2013	Supplement 16Labeling	Approved	Label Letter
Oct 24, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 14, 2010	Supplement 14Labeling	Approved	Letter Label
Dec 14, 2010	Supplement 13Labeling	Approved	Letter Label
Dec 30, 2009	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 2, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 22, 2004	Supplement 5Labeling · Standard review	Approved	Letter
Mar 12, 2003	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 21438
Drugs@FDA: Overview at FDA
Company: ANI 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