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Last Updated: January 23, 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. 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. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.
Summary for 021762
Ingredient:alendronate sodium; cholecalciferol
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
Patent:  Start TrialPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?

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:

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