Orange Book product · Brand (NDA)

ACETADOTE

ACETYLCYSTEINE

Brand (NDA)NDA 021539TE APRX CUMBERLAND PHARMS

Jan 23, 2004

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 23, 2004
22 yr 9 mo ago
Patent 8148356 expires
Listed drug product patent expiration.
May 21, 2026
29 d ago
Today
Exclusivity ends · D-196
New indication / change exclusivity (3 years)
Nov 26, 2027
in 1 yr 6 mo
Patent 9327028 expires
Listed method-of-use patent (U-1839) expiration.
Jul 21, 2031
in 5 yr 2 mo
Patent 8722738 expires
Listed method-of-use patent (U-1373) expiration.
Apr 06, 2032
in 5 yr 11 mo

Active ingredient

ACETYLCYSTEINE

Strength

6GM/30ML (200MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 021539

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8148356	May 21, 2026	29 d ago	Product
9327028	Jul 21, 2031	in 5 yr 2 mo	U-1839
8722738	Apr 06, 2032	in 5 yr 11 mo	U-1373