Orange Book product · Generic (ANDA)
PHYTONADIONE
PHYTONADIONE
At a glance
Feb 20, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 20, 2019
7 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PHYTONADIONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 210189
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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.

