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Generic Name: alendronate sodium

Summary for Generic Name: alendronate sodium

Tradenames:2
Patents:11
Applicants:1
NDAs:3
Drug Master File Entries: see list25
Suppliers: see list3
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: alendronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: alendronate sodium

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

A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Status: Completed Condition: Osteoporosis

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

Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Status: Completed Condition: Healthy

Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Status: Completed Condition: Osteoporosis

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Status: Withdrawn Condition: Hyperparathyroidism

FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267 AM3)(COMPLETED)
Status: Completed Condition: Osteoporosis

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Status: Completed Condition: Osteoporosis

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

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Patented / Exclusive Use
Merck
FOSAMAX
alendronate sodium
SOLUTION; ORAL021575Sep 17, 2003RXYes<disabled>ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
Merck
FOSAMAX
alendronate sodium
SOLUTION; ORAL021575Sep 17, 2003RXYes<disabled>INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
Merck
FOSAMAX
alendronate sodium
SOLUTION; ORAL021575Sep 17, 2003RXYes4,621,077*PED<disabled>
Merck
FOSAMAX
alendronate sodium
SOLUTION; ORAL021575Sep 17, 2003RXYes5,462,932<disabled>
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