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Details for Generic Name: alendronate sodium

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Summary for Generic Name: alendronate sodium

Drug Master File Entries: see list25
Suppliers: see list3
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: alendronate sodium

Drug ClassBisphosphonate

Clinical Trials for: alendronate sodium

The Effects of Alendronate After Cure of Primary Hyperparathyroidism
Status: Withdrawn Condition: Hyperparathyroidism

Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Healthy

Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury Previously Treated With Teriparatide
Status: Enrolling by invitation Condition: Spinal Cord Injury; Bone Loss; Osteoporosis

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
Status: Completed Condition: Cystic Fibrosis; Osteoporosis; Bone Diseases, Metabolic

A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)(COMPLETED)
Status: Completed Condition: Osteoporosis

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Status: Completed Condition: Osteopenia; Osteoporosis

Alendronate in Juvenile Osteoporosis
Status: Completed Condition: Juvenile Osteoporosis; Low Bone Density; Fractures

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Status: Completed Condition: Osteoporosis

Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Status: Completed Condition: Osteoporosis

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
Status: Completed Condition: Postmenopausal Osteoporosis

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
alendronate sodium
TABLET; ORAL020560Oct 20, 2000RXYes4,621,077*PED<disabled><disabled>
alendronate sodium
TABLET; ORAL020560Oct 20, 2000RXNo5,849,726*PED<disabled><disabled>
alendronate sodium
TABLET; ORAL020560Oct 20, 2000RXNo6,015,801*PED<disabled><disabled>
alendronate sodium; cholecalciferol
TABLET; ORAL021762Apr 7, 2005RXYes5,994,329*PED<disabled><disabled>
alendronate sodium
TABLET; ORAL020560Oct 20, 2000RXNo6,225,294*PED<disabled><disabled>
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