Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078803
Company: ACTAVIS TOTOWA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP No Yes
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription AP No 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
08/08/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/31/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

03/20/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OXALIPLATIN

INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 078803 ACTAVIS TOTOWA
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 078819 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207385 GLAND PHARMA LTD
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 200979 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 50MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 204616 QILU PHARM CO LTD

INJECTABLE;INTRAVENOUS; 100MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 078803 ACTAVIS TOTOWA
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 078819 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 207385 GLAND PHARMA LTD
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 200979 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 100MG/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 204616 QILU PHARM CO LTD

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