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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021386
Company: NOVARTIS

Other Important Information from FDA

Products on NDA 021386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOMETA	ZOLEDRONIC ACID	EQ 4MG BASE/VIAL	INJECTABLE; IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2002	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2011	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021386s004ltr.pdf
02/27/2004	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf

Labels for NDA 021386

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf
02/27/2004	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf
02/22/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf

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