Orange Book product · Brand (NDA)
FINACEA
AZELAIC ACID
At a glance
Dec 24, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
AZELAIC ACID
Strength
15%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 021470
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
- 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
- 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.
