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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Farmers Insurance
US Department of Justice

Generated: January 22, 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
Ingredient:alendronate sodium; cholecalciferol
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 0006-0270-21 2 BLISTER PACK in 1 CARTON (0006-0270-21) > 10 TABLET in 1 BLISTER PACK (0006-0270-01)
FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762 NDA Merck Sharp & Dohme Corp. 0006-0270 0006-0270-44 4 TABLET in 1 BLISTER PACK (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:➤ SubscribePatent 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

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Federal Trade Commission
Argus Health

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