Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207963
Company: HIKMA

• Summary Review

Products on NDA 207963

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207963s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207963Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207963Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207963Orig1s000SumR.pdf

Labels for NDA 207963

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207963s000lbl.pdf