Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205580
Company: EAGLE PHARMS
Company: EAGLE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BELRAPZO | 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 |
---|---|---|---|---|---|---|---|
05/15/2018 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205580s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205580Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/11/2024 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205580Orig1s013ltr.pdf | |
06/02/2022 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205580Orig1s012Corrected_ltr.pdf | |
10/14/2021 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205580Orig1s010ltr.pdf | |
10/30/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205580Orig1s006ltr.pdf | |
08/31/2018 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/11/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf | |
06/02/2022 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf | |
06/02/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf | |
10/14/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf | |
10/30/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf | |
08/31/2018 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf | |
08/31/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf | |
05/15/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf |
BELRAPZO
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 |