Orange Book product · Generic (ANDA)
AZELAIC ACID
AZELAIC ACID
At a glance
Nov 19, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 19, 2018
7 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
AZELAIC ACID
Strength
15%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
ANDA 204637
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AZELAIC ACID
- 2015FINACEABrand (NDA)
NDA 207071 · LEO PHARMA AS
- 2002FINACEABrand (NDA)
NDA 021470 · LEO PHARMA AS
- 1995AZELEXBrand (NDA)
NDA 020428 · ALMIRALL
- 2020AZELAIC ACIDGeneric (ANDA)
ANDA 210928 · AUROBINDO PHARMA USA
- 2019AZELAIC ACIDGeneric (ANDA)
ANDA 210549 · SUN PHARMA CANADA
- 2018AZELAIC ACIDGeneric (ANDA)
ANDA 208011 · ACTAVIS LABS UT INC
- 2018AZELAIC ACIDGeneric (ANDA)
ANDA 208724 · ENCUBE
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.
