Application Nr Approved Date Route Status External Links
ANDA203822 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Risedronate Sodium Delayed-Release Tablets Are A Bisphosphonate In A Delayed-Release Formulation And Is Indicated For Treatment Of Postmenopausal Osteoporosis ( 1.1 ) Limitations Of Use Optimal Duration Of Use Has Not Been Determined. For Patients At Low-Risk For Fracture, Consider Drug Discontinuation After 3 To 5 Years Of Use ( 1.2 ) 1.1 Postmenopausal Osteoporosis Risedronate Sodium Delayed-Release Tablets Are Indicated For The Treatment Of Osteoporosis In Postmenopausal Women. In Postmenopausal Women, Risedronate Sodium Has Been Shown To Reduce The Incidence Of Vertebral Fractures And A Composite Endpoint Of Nonvertebral Osteoporosis-Related Fractures [ See Clinical Studies ( 14.1 ) ]. 1.2 Important Limitations Of Use The Optimal Duration Of Use Has Not Been Determined. The Safety And Effectiveness Of Risedronate Sodium Delayed-Release Tablets For The Treatment Of Osteoporosis Are Based On Clinical Data Of One Year Duration. All Patients On Bisphosphonate Therapy Should Have The Need For Continued Therapy Re-Evaluated On A Periodic Basis. Patients At Low-Risk For Fracture Should Be Considered For Drug Discontinuation After 3 To 5 Years Of Use. Patients Who Discontinue Therapy Should Have Their Risk For Fracture Re-Evaluated Periodically.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Risedronate Sodium Anhydrous

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