Orange Book product · Brand (NDA)
ABREVA
DOCOSANOL
At a glance
Jul 25, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2000
26 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DOCOSANOL
Strength
10%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 020941
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.
- 2025DOCOSANOLGeneric (ANDA)
ANDA 215505 · DR REDDYS
- 2025DOCOSANOLGeneric (ANDA)
ANDA 214613 · DR REDDYS
- 2024DOCOSANOLGeneric (ANDA)
ANDA 217090 · AUROBINDO PHARMA LTD
- 2023DOCOSANOLGeneric (ANDA)
ANDA 214454 · SUN PHARMA CANADA
- 2022DOCOSANOLGeneric (ANDA)
ANDA 212385 · P AND L DEVELOPMENT
- 2022DOCOSANOLGeneric (ANDA)
ANDA 215839 · ALEMBIC
- 2018DOCOSANOLGeneric (ANDA)
ANDA 208754 · P AND L
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.
