Orange Book product · Generic (ANDA)
POSACONAZOLE
POSACONAZOLE
At a glance
Dec 23, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
POSACONAZOLE
Strength
300MG/16.7ML (18MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 219057
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POSACONAZOLE
- 2021NOXAFIL POWDERMIX KITBrand (NDA)
NDA 214770 · MSD MERCK CO
- 2014NOXAFILBrand (NDA)
NDA 205596 · MERCK SHARP DOHME
- 2013NOXAFILBrand (NDA)
NDA 205053 · MERCK SHARP DOHME
- 2006NOXAFILBrand (NDA)
NDA 022003 · SCHERING
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 217720 · QILU PHARM HAINAN
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 218434 · MSN
- 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.

