Orange Book product · Brand (NDA)
MICAFUNGIN
MICAFUNGIN SODIUM
At a glance
Jun 16, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 16, 2021
5 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MICAFUNGIN SODIUM
Strength
EQ 100MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212156
Product number
002
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.
- 2023MICAFUNGIN IN SODIUM CHLORIDE 0.9%Brand (NDA)
NDA 216142 · BAXTER HLTHCARE CORP
- 2021MICAFUNGINBrand (NDA)
NDA 212125 · TEVA PHARMS USA INC
- 2005MYCAMINEBrand (NDA)
NDA 021506 · ASTELLAS
- 2026MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 220296 · ASPIRO
- 2026MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 219518 · YICHANG HUMANWELL
- 2026MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 219712 · HISUN PHARM HANGZHOU
- 2025MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 219273 · QILU PHARM HAINAN
- 2024MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 216438 · BIOCON PHARMA
- 2022MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 215241 · ZYDUS PHARMS
- 2022MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 215381 · MEITHEAL
- 2021MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 213261 · HIKMA
- 2021MICAFUNGIN SODIUMGeneric (ANDA)
ANDA 213363 · JIANGSU HANSOH PHARM
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.
