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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078811
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS 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
06/10/2010 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
11/18/2021 SUPPL-19 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/18/2019 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/04/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/05/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/04/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

05/13/2014 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

OXALIPLATIN

INJECTABLE;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELOXATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021759 SANOFI AVENTIS US
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207474 ACCORD HLTHCARE
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204880 ACTAVIS LLC
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205529 EUGIA PHARMA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078811 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090030 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207325 GLAND
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203869 HENGRUI PHARMA
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078813 HOSPIRA WORLDWIDE
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091358 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207562 NOVAST LABS
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204368 QILU PHARM HAINAN
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078817 SANDOZ
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022160 TEVA PHARMS

INJECTABLE;INTRAVENOUS; 100MG/20ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELOXATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021759 SANOFI AVENTIS US
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207474 ACCORD HLTHCARE
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204880 ACTAVIS LLC
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205529 EUGIA PHARMA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078811 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090030 FRESENIUS KABI USA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207325 GLAND
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203869 HENGRUI PHARMA
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078813 HOSPIRA WORLDWIDE
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 091358 MYLAN LABS LTD
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207562 NOVAST LABS
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204368 QILU PHARM HAINAN
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription No AP 078817 SANDOZ
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022160 TEVA PHARMS
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