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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090124
Company: AUROBINDO PHARMA

Other Important Information from FDA

Products on ANDA 090124

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 090124

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2008	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
04/08/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/22/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/22/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/22/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/05/2013	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/25/2012	SUPPL-6	Labeling-Medication Guide, REMS-Modified		Label is not available on this site.
05/17/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/06/2011	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal		Label is not available on this site.
02/15/2011	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
08/24/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/19/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 090124

ALENDRONATE SODIUM

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

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