Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078816
Company: MUSTAFA NEVSAT IIAC SANAYII A.S.

Products on ANDA 078816

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXALIPLATIN	OXALIPLATIN	5MG/ML	INJECTABLE; INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078816

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	Tentative Approval				Label is not available on this site.