Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210204
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
05/02/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BORTEZOMIB
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 3.5MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 205533 | APOTEX |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 213823 | BAXTER HLTHCARE CORP |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 202963 | DR REDDYS |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212825 | EUGIA PHARMA |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209659 | FRESENIUS KABI USA |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212204 | HETERO LABS LTD VI |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208460 | HOSPIRA |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 215011 | JIANGSU HANSOH PHARM |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212958 | MEITHEAL |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209622 | MSN |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208392 | PHARMASCIENCE INC |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 210824 | QILU PHARM HAINAN |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 211898 | RELIANCE LIFE SCI |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 203654 | SANDOZ |
BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 210204 | ZYDUS PHARMS |
VELCADE | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 021602 | TAKEDA PHARMS USA |