Orange Book product · Brand (NDA)
AZELEX
AZELAIC ACID
At a glance
Sep 13, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 13, 1995
31 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AZELAIC ACID
Strength
20%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 020428
Product number
001
Marketing status
RX
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.
- 2015FINACEABrand (NDA)
NDA 207071 · LEO PHARMA AS
- 2002FINACEABrand (NDA)
NDA 021470 · LEO PHARMA AS
- 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
- 2018AZELAIC ACIDGeneric (ANDA)
ANDA 204637 · GLENMARK SPECLT
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.
