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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077132
Company: TEVA PHARMS USA

Other Important Information from FDA

Products on ANDA 077132

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	AB	No	No
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	AB	No	No
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077132

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2007	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077132s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2023	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/14/2020	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/16/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/05/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/16/2015	SUPPL-3	Labeling-Package Insert, REMS-Proposal		Label is not available on this site.

Labels for ANDA 077132

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/05/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077132s000lbl.pdf

Therapeutic Equivalents for ANDA 077132

RISEDRONATE SODIUM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	205280	ORBION PHARMS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

TABLET;ORAL; 35MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTONEL	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	Yes	AB	020835	APIL
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	090877	APOTEX
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	200296	AUROBINDO PHARMA LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	203533	MACLEODS PHARMS LTD
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	205280	ORBION PHARMS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET;ORAL	Prescription	No	AB	077132	TEVA PHARMS USA

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