Orange Book product · Brand (NDA)
ABLYSINOL
DEHYDRATED ALCOHOL
At a glance
Jun 21, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 21, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DEHYDRATED ALCOHOL
Strength
99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRA-ARTERIAL
TE code
Not listed
Application
NDA 207987
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025DEHYDRATED ALCOHOLBrand (NDA)
NDA 214988 · ROYAL PHARMS
- 2025DEHYDRATED ALCOHOLGeneric (ANDA)
ANDA 219569 · INGENUS PHARMS LLC
- 2025DEHYDRATED ALCOHOLGeneric (ANDA)
ANDA 217845 · ACCORD HLTHCARE
- 2025DEHYDRATED ALCOHOLGeneric (ANDA)
ANDA 219444 · BRECKENRIDGE
- 2025DEHYDRATED ALCOHOLGeneric (ANDA)
ANDA 219400 · XGEN PHARMS
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.
