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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 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 NDA: 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 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 70MG BASE;2,800 IU
Approval Date:Apr 7, 2005TE:RLD:No
Patent:5,994,329*PEDPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

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

Expired Orange Book Patents for NDA: 021762

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 20054,621,077*PED► subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20074,621,077*PED► subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20075,681,590*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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