Propranolol Hydrochloride

ANDA 76400, held by Sciegen Pharms. Propranolol Hydrochloride.

As of Nov 15, 2026, ANDA 76400 (Propranolol Hydrochloride), held by Sciegen Pharms, was first approved by FDA on Feb 26, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 26, 2003
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
Feb 26, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propranolol Hydrochloride1MG/ML · injectable;injection	Propranolol Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 17, 2009	Supplement 3Labeling	Approved	None posted
Feb 26, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76400
Drugs@FDA: Overview at FDA
Company: ScieGen 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