Home Applications 050560 Application 050560
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFIZOX CEFTIZOXIME SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 002 CEFIZOX CEFTIZOXIME SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 003 CEFIZOX CEFTIZOXIME SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 005 CEFIZOX CEFTIZOXIME SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N050560-001 CEFIZOX CEFTIZOXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 N050560-002 CEFIZOX CEFTIZOXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 N050560-003 CEFIZOX CEFTIZOXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 N050560-005 CEFIZOX CEFTIZOXIME SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19
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 · 164 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 2026-02-19 14:30 UTC 2026-02 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050560-001 CEFIZOX EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050560-002 CEFIZOX EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050560-003 CEFIZOX EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1983-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050560-005 CEFIZOX EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1993-03-19 d06236e962d9…
Documents# Document, Submission type, Date table Document Submission type Date 30081 SUPPL 2005-01-21