Isoniazid

As of Nov 13, 2026, NDA 8428 (Isoniazid), held by Panray, was not approved, with 12 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 12
Complete response letters: 0

Products

3 strengths and forms


Isoniazid50MG · tablet;oral	Isoniazid	Discontinued
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued
Isoniazid300MG · tablet;oral	Isoniazid	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Apr 3, 1980	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 14, 1979	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 19, 1978	Supplement 14Labeling	Approved	None posted
Jun 19, 1978	Supplement 15Labeling	Approved	None posted
Jun 13, 1978	Supplement 13Labeling	Approved	None posted
Apr 20, 1978	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 25, 1977	Supplement 10Labeling	Approved	None posted
Apr 13, 1977	Supplement 8Labeling	Approved	None posted
Apr 6, 1977	Supplement 9Labeling	Approved	None posted
Mar 1, 1976	Supplement 7Labeling	Approved	None posted
Jun 11, 1973	Supplement 3	Approved	None posted

Identifiers

Application: NDA 8428
Drugs@FDA: Overview at FDA
Company: Panray

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