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Medtronic
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021762

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NDA 021762 describes FOSAMAX PLUS D, which is a drug marketed by Merck and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FOSAMAX PLUS D profile page.

The generic ingredient in FOSAMAX PLUS D 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 021762
Tradename:FOSAMAX PLUS D
Applicant:Merck
Ingredient:alendronate sodium; cholecalciferol
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021762
Suppliers and Packaging for NDA: 021762
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762 NDA Merck Sharp & Dohme Corp. 0006-0270 N 0006-0270-21
FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762 NDA Merck Sharp & Dohme Corp. 0006-0270 N 0006-0270-44

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;2,800 IU
Approval Date:Apr 7, 2005TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;5,600 IU
Approval Date:Apr 26, 2007TE:RLD:Yes

Expired US Patents for NDA 021762

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Baxter
Colorcon
US Army
Argus Health
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Moodys
Fuji
Cipla

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