Phenelzine Sulfate

ANDA 200181, held by Novel Labs Inc. Phenelzine Sulfate.

As of Nov 15, 2026, ANDA 200181 (Phenelzine Sulfate), held by Novel Labs Inc, was first approved by FDA on Dec 8, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 8, 2010
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
Dec 8, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phenelzine SulfateEQ 15MG BASE · tablet;oral	Phenelzine Sulfate	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 17, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Dec 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 200181
Drugs@FDA: Overview at FDA
Company: Novel Laboratories

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