Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204016
Company: HOSPIRA

Products on NDA 204016

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204016

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204016s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204016Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204016Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204016Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204016s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204016Orig1s003Ltr.pdf
04/29/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204016

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204016s003lbl.pdf
12/28/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204016s000lbl.pdf