Orange Book product · Generic (ANDA)
DOCOSANOL
DOCOSANOL
At a glance
Oct 26, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 26, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DOCOSANOL
Strength
10%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
ANDA 214454
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DOCOSANOL
- 2000ABREVABrand (NDA)
NDA 020941 · HALEON US HOLDINGS
- 2025DOCOSANOLGeneric (ANDA)
ANDA 215505 · DR REDDYS
- 2025DOCOSANOLGeneric (ANDA)
ANDA 214613 · DR REDDYS
- 2024DOCOSANOLGeneric (ANDA)
ANDA 217090 · AUROBINDO PHARMA LTD
- 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.
