Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215033
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/07/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215033s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215033Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215033Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/15/2024 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215033s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215033Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/15/2024 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215033s003lbl.pdf | |
12/07/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215033s000lbl.pdf |
BENDAMUSTINE HYDROCHLORIDE
SOLUTION;INTRAVENOUS; 100MG/4ML (25MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BELRAPZO | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 205580 | EAGLE PHARMS |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 215033 | APOTEX |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 216078 | BAXTER HLTHCARE CORP |