Nadolol

ANDA 74255, held by Heritage Pharma. Nadolol.

As of Nov 15, 2026, ANDA 74255 (Nadolol), held by Heritage Pharma, was first approved by FDA on Jan 24, 1996, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1996
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 24, 1996	Original application	Approved	None posted

Products

3 strengths and forms


Nadolol80MG · tablet;oral	Nadolol	Discontinued
Nadolol120MG · tablet;oral	Nadolol	Discontinued
Nadolol160MG · tablet;oral	Nadolol	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 16, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Apr 16, 2015	Supplement 18Labeling	Approved	None posted
Apr 16, 2015	Supplement 16Labeling	Approved	None posted
Jul 29, 2002	Supplement 7Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 6Manufacturing	Approved	None posted
Jul 31, 2001	Supplement 4Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 3Manufacturing	Approved	None posted
Apr 6, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 6, 1998	Supplement 1Manufacturing	Approved	None posted
Jan 24, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74255
Drugs@FDA: Overview at FDA
Company: Heritage 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