Orange Book product · Generic (ANDA)
PHYTONADIONE
PHYTONADIONE
At a glance
Dec 19, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PHYTONADIONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 212112
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PHYTONADIONE
- —AQUAMEPHYTONBrand (NDA)
NDA 012223 · PAI HOLDINGS PHARM
- —KONAKIONBrand (NDA)
NDA 011745 · ROCHE
- —MEPHYTONBrand (NDA)
NDA 010104 · BAUSCH
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 217734 · AMNEAL
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 215820 · DR REDDYS
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 216298 · ORBICULAR
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 216852 · BAXTER HLTHCARE CORP
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 220454 · SINOTHERAPEUTICS INC
- 2026PHYTONADIONEGeneric (ANDA)
ANDA 215090 · SUNNY
- 2025PHYTONADIONEGeneric (ANDA)
ANDA 216601 · AMNEAL
- 2025PHYTONADIONEGeneric (ANDA)
ANDA 216444 · ALEMBIC
- 2025PHYTONADIONEGeneric (ANDA)
ANDA 219212 · CAPLIN
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.
