FDA Orange Book · active-ingredient family
Dehydrated alcohol
Dehydrated alcohol is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEHYDRATED ALCOHOL · NDA 214988
2
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEHYDRATED ALCOHOLRLD | ROYAL PHARMS | NDA 214988 | — | Oct 23, 2025 | |
| ABLYSINOLRLD×2 | BPI LABS | NDA 207987 | — | Jun 21, 2018 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEHYDRATED ALCOHOL | INGENUS PHARMS LLC | ANDA 219569 | AP | Jul 09, 2025 | |
| DEHYDRATED ALCOHOL | ACCORD HLTHCARE | ANDA 217845 | AP | Jun 23, 2025 | |
| DEHYDRATED ALCOHOL | BRECKENRIDGE | ANDA 219444 | AP | Jun 23, 2025 | |
| DEHYDRATED ALCOHOL | XGEN PHARMS | ANDA 219400 | AP | Jun 23, 2025 |
Marketing exclusivity (1)
- ODE-521Orphan-drug exclusivity (7 years)
Oct 23, 2032
in 6 yr 5 mo
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.
Dehydrated alcohol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
