Alendronate Sodium Trihydrate

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

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USFDA APPLICATION NUMBER - 20560 / DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)	ALENDRONIC ACID	70mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.
ANHYDROUS LACTOSE(3SY5LH9PMK)
CROSCARMELLOSE SODIUM(M28OL1HH48)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)

Setid F2dcfb39 A7c2 4e39 9e35 852a3a74f947 Applno 20560 Form Tablet Oral Dosage Eq 10mg Base - Drug Product Composition: Alendronate Sodium Trihydrate