Orange Book product · Generic (ANDA)
POSACONAZOLE
POSACONAZOLE
At a glance
Feb 24, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 24, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
POSACONAZOLE
Strength
100MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 218434
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
- 2024POSACONAZOLEGeneric (ANDA)
ANDA 219057 · ASPIRO
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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.
