Home Applications 217021 Application 217021
Type ANDA
Sponsor HAINAN POLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL No No 002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL No No 003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 005 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217021-001 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 A217021-005 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 3 · 91 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 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217021-005 LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-003 LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217021-004 LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217021-001 LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217021-002 LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2023-07-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.