FDA Orange Book · active-ingredient family
Chlorhexidine gluconate; isopropyl alcohol
Chlorhexidine gluconate; isopropyl alcohol is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SOLUPREP S · NDA 208288
4
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution, sponge, swab
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOLUPREP SRLD | SOLVENTUM | NDA 208288 | — | Aug 08, 2018 | |
| PREVANTICS MAXI SWABSTICKRLD×3 | PROF DSPLS | NDA 021524 | — | Jun 03, 2005 | |
| CHLORAPREP ONE-STEP SEPPRLD×3 | BECTON DICKINSON CO | NDA 021555 | — | Oct 07, 2002 | |
| CHLORAPREP ONE-STEPRLD×8 | BECTON DICKINSON CO | NDA 020832 | — | Jul 14, 2000 |
Marketing exclusivity (1)
- M-292New use / labeling-change exclusivity (3 years)
Jan 20, 2026
5 mo ago
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7422388 | Apr 25, 2027 | in 10 mo | ProductU-1397 |
Chlorhexidine gluconate; isopropyl alcohol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
