FDA Orange Book · active-ingredient family
Alcohol; chlorhexidine gluconate
Alcohol; chlorhexidine gluconate: 1 brand, 0 generics; first approved Jun 07, 2001.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- SOLVENTUMNDA 0210742001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 61%;1% SOLUTION TOPICAL OTC —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
25 yr 6 mo ago
Most recent approval
25 yr 6 mo ago
All 1 application were approved in 2001.
Brand (NDA) 1100%
Generic (ANDA) 00%
Alcohol; chlorhexidine gluconate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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