Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090258
Company: HANGZHOU BINJIANG

Products on ANDA 090258

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090258

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2009	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
04/18/2017	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
09/26/2012	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/16/2012	SUPPL-4	Labeling-Package Insert, REMS-Proposal		Label is not available on this site.
03/29/2013	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090258

ALENDRONATE SODIUM

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077982	APOTEX
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	076768	CIPLA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	090258	HANGZHOU BINJIANG
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	090022	SUN PHARM

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077982	APOTEX
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090124	AUROBINDO PHARMA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076768	CIPLA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090258	HANGZHOU BINJIANG
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090022	SUN PHARM

TABLET;ORAL; EQ 35MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	077982	APOTEX
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	090124	AUROBINDO PHARMA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	076768	CIPLA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	090258	HANGZHOU BINJIANG
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	090022	SUN PHARM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET;ORAL	Prescription	No	AB	076984	WATSON LABS

TABLET;ORAL; EQ 70MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	077982	APOTEX
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	090124	AUROBINDO PHARMA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	076768	CIPLA
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	090258	HANGZHOU BINJIANG
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	090022	SUN PHARM
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	No	AB	076984	WATSON LABS
FOSAMAX	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET;ORAL	Prescription	Yes	AB	020560	ORGANON