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Details for New Drug Application (NDA): 020560

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NDA 020560 describes FOSAMAX, which is a drug marketed by Merck And Co Inc and Merck and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSAMAX profile page.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for NDA: 020560

Tradename:
FOSAMAX
Applicant:
Merck And Co Inc
Ingredient:
alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020560

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 020560

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAMAX
alendronate sodium
TABLET;ORAL 020560 NDA Merck Sharp & Dohme Corp. 0006-0031 0006-0031-44 4 TABLET in 1 BLISTER PACK (0006-0031-44)
FOSAMAX
alendronate sodium
TABLET;ORAL 020560 NDA Physicians Total Care, Inc. 54868-3857 54868-3857-0 30 TABLET, COATED in 1 BOTTLE (54868-3857-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 29, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 29, 1995TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 25, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020560

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-005Oct 20, 20005,358,941*PED► subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19955,681,590*PED► subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19976,090,410*PED► subscribe
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