Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205574
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | AP | No | No |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | AP | No | No |
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 | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205574Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/07/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf |
BENDAMUSTINE HYDROCHLORIDE
POWDER;IV (INFUSION); 25MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205574 | ACCORD HLTHCARE |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 204230 | APOTEX |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205447 | BRECKENRIDGE |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205376 | DR REDDYS |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 214739 | EUGIA PHARMA |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 211001 | MEITHEAL |
TREANDA | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER;IV (INFUSION) | Prescription | Yes | AP | 022249 | CEPHALON |
POWDER;IV (INFUSION); 100MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205574 | ACCORD HLTHCARE |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 204230 | APOTEX |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205447 | BRECKENRIDGE |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 205376 | DR REDDYS |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 214739 | EUGIA PHARMA |
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | No | AP | 211001 | MEITHEAL |
TREANDA | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER;IV (INFUSION) | Prescription | Yes | AP | 022249 | CEPHALON |