Orange Book product · Generic (ANDA)
VITAMIN K1
PHYTONADIONE
At a glance
Jul 25, 1983
Approved
Generic (ANDA)
Application
BP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 1983
43 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PHYTONADIONE
Strength
1MG/0.5ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
BP
Application
ANDA 087954
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
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.
