Isoniazid

ANDA 80120, held by Whiteworth Town Plsn. Isoniazid.

As of Nov 15, 2026, ANDA 80120 (Isoniazid), held by Whiteworth Town Plsn, was first approved by FDA on Apr 14, 1971, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 14, 1971
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Apr 14, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isoniazid100MG · tablet;oral	Isoniazid	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 4, 1985	Supplement 16Manufacturing	Approved	None posted
Dec 4, 1985	Supplement 15Manufacturing	Approved	None posted
Apr 14, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80120
Drugs@FDA: Overview at FDA
Company: Whiteworth Town Plsn

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