Orange Book product · Brand (NDA)
NOXAFIL
POSACONAZOLE
At a glance
Sep 15, 2006
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2006
20 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
POSACONAZOLE
Strength
40MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 022003
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.
- 2021NOXAFIL POWDERMIX KITBrand (NDA)
NDA 214770 · MSD MERCK CO
- 2014NOXAFILBrand (NDA)
NDA 205596 · MERCK SHARP DOHME
- 2013NOXAFILBrand (NDA)
NDA 205053 · MERCK SHARP DOHME
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 217720 · QILU PHARM HAINAN
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 218434 · MSN
- 2024POSACONAZOLEGeneric (ANDA)
ANDA 219057 · ASPIRO
- 2024POSACONAZOLEGeneric (ANDA)
ANDA 217119 · AUROBINDO PHARMA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 214842 · EUGIA PHARMA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 209983 · FRESENIUS KABI USA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 217553 · GLAND
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 211500 · MYLAN LABS LTD
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 216488 · I 3 PHARMS
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.
