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Last Updated: August 8, 2020

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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 one supplier. 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. One supplier is 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:0
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)
Paragraph IV (Patent) Challenges for 021762
Tradename Dosage Ingredient NDA Submissiondate
FOSAMAX PLUS D TABLET;ORAL alendronate sodium; cholecalciferol 021762 2007-11-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;2,800 IU
Approval Date:Apr 7, 2005TE:RLD:Yes

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

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
Boehringer Ingelheim
McKinsey
Mallinckrodt
McKesson

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