Orange Book product · Brand (NDA)
AQUAMEPHYTON
PHYTONADIONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PHYTONADIONE
Strength
10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 012223
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —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
- 2025PHYTONADIONEGeneric (ANDA)
ANDA 214966 · CIPLA
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.
