Home Applications 003718 Application 003718
Type NDA
Sponsor ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 004 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE INJECTABLE;INJECTION 5MG/ML No No 006 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE INJECTABLE;INJECTION 10MG/ML No No 008 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE INJECTABLE;INJECTION 37.5MG/ML No No 010 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE TABLET;ORAL 5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N003718-004 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE 5MG/ML INJECTABLE / INJECTION Approved before 1982 N003718-006 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE 10MG/ML INJECTABLE / INJECTION Approved before 1982 N003718-008 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 N003718-010 SYNKAYVITE MENADIOL SODIUM DIPHOSPHATE 5MG TABLET / ORAL Approved before 1982
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N003718-004 SYNKAYVITE 5MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N003718-006 SYNKAYVITE 10MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N003718-008 SYNKAYVITE 37.5MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N003718-010 SYNKAYVITE 5MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.