Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078818
Company: SUN PHARM

Products on ANDA 078818

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No
OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078818

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2009	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
03/20/2013	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078818Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078818Orig1s002ltr.pdf

Labels for ANDA 078818

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2013	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078818Orig1s002lbl.pdf