Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 079215
Company: TEVA PHARMS USA

Products on ANDA 079215

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2014	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
05/24/2023	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/28/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079215

RISEDRONATE SODIUM

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTONEL	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	Yes	AB	020835	APIL
RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	No	AB	090877	APOTEX
RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	No	AB	206768	AUROBINDO PHARMA
RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	No	AB	090886	SUN PHARM
RISEDRONATE SODIUM	RISEDRONATE SODIUM	150MG	TABLET;ORAL	Prescription	No	AB	079215	TEVA PHARMS USA