Cetylev

NDA 207916, held by Arbor Pharms LLC. Acetylcysteine.

As of Nov 13, 2026, NDA 207916 (Cetylev), held by Arbor Pharms LLC, was first approved by FDA on Jan 29, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2016
Review: Standard
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
Jan 29, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Cetylev500MG · tablet, effervescent;oral	Acetylcysteine	DiscontinuedReference drug
Cetylev2.5GM · tablet, effervescent;oral	Acetylcysteine	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Mar 16, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Jul 20, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Apr 18, 2017	Supplement 3Labeling · Standard review	Approved	Label Letter
Jan 29, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 207916
Drugs@FDA: Overview at FDA
Company: Arbor 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