Orange Book product · Brand (NDA)
SOLUPREP S
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
At a glance
Aug 08, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 08, 2018
8 yr ago
Exclusivity ends · M-292
New use / labeling-change exclusivity (3 years)
Jan 20, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Strength
2%;70%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 208288
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-292New use / labeling-change exclusivity (3 years)
Jan 20, 2026
5 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
