Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091170
Company: BRECKENRIDGE

Products on ANDA 091170

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/5ML	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091170

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2013	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
02/21/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/21/2020	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/24/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/25/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/25/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/31/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.