FDA Orange Book · active-ingredient family
Phytonadione
Phytonadione is approved as 3 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AQUAMEPHYTON · NDA 012223
3
Brand (NDA)
24
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AQUAMEPHYTONRLD×2 | PAI HOLDINGS PHARM | NDA 012223 | — | Approved Prior to Jan 1, 1982 | |
| MEPHYTONRLD | BAUSCH | NDA 010104 | — | Approved Prior to Jan 1, 1982 | |
| KONAKION×2 | ROCHE | NDA 011745 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (24)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHYTONADIONE | AMNEAL | ANDA 217734 | AB1 | Jun 01, 2026 | |
| PHYTONADIONE | DR REDDYS | ANDA 215820 | AB1 | May 15, 2026 | |
| PHYTONADIONE | ORBICULAR | ANDA 216298 | AB1 | Mar 13, 2026 | |
| PHYTONADIONE | BAXTER HLTHCARE CORP | ANDA 216852 | AB2 | Feb 26, 2026 | |
| PHYTONADIONE | SINOTHERAPEUTICS INC | ANDA 220454 | AB | Feb 26, 2026 | |
| PHYTONADIONE | SUNNY | ANDA 215090 | AB1 | Jan 09, 2026 | |
| PHYTONADIONE | AMNEAL | ANDA 216601 | AB1 | Nov 04, 2025 | |
| PHYTONADIONE | ALEMBIC | ANDA 216444 | AB1 | Sep 08, 2025 | |
| PHYTONADIONE | CAPLIN | ANDA 219212 | AB1 | Apr 17, 2025 | |
| PHYTONADIONE | CIPLA | ANDA 214966 | AB1 | Jan 03, 2025 | |
| PHYTONADIONE | HIKMA | ANDA 212112 | — | Dec 19, 2024 | |
| PHYTONADIONE | GLAND | ANDA 217386 | AB1 | Dec 10, 2024 | |
| PHYTONADIONE | AGNITIO | ANDA 213336 | AB | Oct 12, 2023 | |
| PHYTONADIONE | SCIEGEN PHARMS | ANDA 213329 | AB | Jul 28, 2023 | |
| PHYTONADIONE×2 | CIPLA | ANDA 212424 | — | Apr 22, 2022 | |
| PHYTONADIONE×2 | CIPLA | ANDA 214596 | AB2 | Apr 22, 2022 | |
| PHYTONADIONE | DR REDDYS | ANDA 207719 | AB1 | May 22, 2019 | |
| PHYTONADIONE | ZYDUS LIFESCIENCES | ANDA 210189 | AB | Feb 20, 2019 | |
| PHYTONADIONE | AMNEAL PHARMS CO | ANDA 209373 | AB | May 11, 2018 | |
| VITAMIN K1RLD | HOSPIRA | ANDA 087954 | BP | Jul 25, 1983 | |
| VITAMIN K1RLD | HOSPIRA | ANDA 087955 | AB1 | Jul 25, 1983 | |
| VITAMIN K1 | HOSPIRA | ANDA 087956 | — | Jul 25, 1983 | |
| PHYTONADIONE×2 | GLAXOSMITHKLINE | ANDA 084060 | — | Approved Prior to Jan 1, 1982 | |
| PHYTONADIONERLD | INTL MEDICATION | ANDA 083722 | AB1 | Approved Prior to Jan 1, 1982 |
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.
Phytonadione — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
