Orange Book product · Brand (NDA)

CETYLEV

ACETYLCYSTEINE

Brand (NDA)NDA 207916DISCN ARBOR PHARMS LLC

Jan 29, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 29, 2016
10 yr 6 mo ago
Today
Patent 8747894 expires
Listed drug product patent expiration.
May 08, 2032
in 6 yr
Patent 9427421 expires
Listed drug product patent expiration.
May 08, 2032
in 6 yr
Patent 9561204 expires
Listed method-of-use patent (U-1373) expiration.
May 08, 2032
in 6 yr

Active ingredient

ACETYLCYSTEINE

Strength

2.5GM

Dosage form

TABLET, EFFERVESCENT

Route

ORAL

TE code

Not listed

Application

NDA 207916

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8747894	May 08, 2032	in 6 yr	ProductU-1373
9427421	May 08, 2032	in 6 yr	Product
9561204	May 08, 2032	in 6 yr	U-1373