Laniazid

ANDA 80140, held by Chartwell Molecular. Isoniazid.

As of Nov 15, 2026, ANDA 80140 (Laniazid), held by Chartwell Molecular, was first approved by FDA on Aug 29, 1975, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1975
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 29, 1975	Original application	Approved	None posted

Products

2 strengths and forms


Laniazid50MG · tablet;oral	Isoniazid	Discontinued
Laniazid100MG · tablet;oral	Isoniazid	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Jan 29, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Jan 9, 1990	Supplement 9Labeling	Approved	None posted
Aug 29, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 80140
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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