Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205749
Company: GLAND PHARMA LTD

Products on ANDA 205749

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLEDRONIC	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	AP	No	Yes
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;IV (INFUSION)	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205749

ZOLEDRONIC

INJECTABLE;INTRAVENOUS; EQ 4MG BASE/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLEDRONIC	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205749	GLAND PHARMA LTD
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210174	AMNEAL
ZOLEDRONIC ACID	ZOLEDRONIC ACID	EQ 4MG BASE/100ML	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	203231	INFORLIFE

ZOLEDRONIC ACID

There are no Therapeutic Equivalents.