Home Applications 215033 Application 215033
Type NDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE SOLUTION; INJECTION 25MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215033-001 BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215033-001 AP
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.
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 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-12-07 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215033-001 BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2022-12-07 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 78151 SUPPL 2024-04-16 78145 SUPPL 2024-04-16 75377 ORIG 2023-09-08 72835 ORIG 2022-12-09 70744 ORIG 2022-04-11