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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210204
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
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