Home Applications 020316 Application 020316
Type NDA
Sponsor GUERBET Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXILAN-300 IOXILAN INJECTABLE;INJECTION 62% No No 002 OXILAN-350 IOXILAN INJECTABLE;INJECTION 73% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020316-001 OXILAN-300 IOXILAN 62% INJECTABLE / INJECTION 1995-12-21 N020316-002 OXILAN-350 IOXILAN 73% INJECTABLE / INJECTION 1995-12-21
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 · 82 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 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020316-001 OXILAN-300 62% INJECTABLE / INJECTION 1995-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020316-002 OXILAN-350 73% INJECTABLE / INJECTION 1995-12-21 782e0a99824c…
Documents# Document, Submission type, Date table Document Submission type Date 47961 SUPPL 2017-04-12 47873 SUPPL 2017-04-06 12440 SUPPL 2015-07-23 2328 SUPPL 2015-07-23 2327 SUPPL 2006-11-14 2326 SUPPL 2002-01-06