Alendronate Sodium

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ACTIVE PHARMA INGREDIENTS

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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

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4 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 2 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 7 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 18 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 20560 / DOSAGE - TABLET;ORAL - EQ 70MG BASE

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.	A-S Medication Solutions	Actavis Pharma, Inc.	Amneal Pharmaceuticals of New York LLC	Apotex Corp.	Avera McKennan Hospital	Cipla USA Inc.	DIRECT RX	Direct_Rx	EXELAN PHARMACEUTICALS INC.	Jubilant Cadista Pharmaceuticals Inc.	Marlex Pharmaceuticals Inc	Mylan Institutional Inc.	NuCare Pharmaceuticals,Inc.	RedPharm Drug, Inc	REMEDYREPACK INC.	Sun Pharma Global FZE	Sun Pharma Global Inc.	Unit Dose Services	Bryant Ranch Prepack	Golden State Medical Supply, Inc.	Preferred Pharmaceuticals Inc.	Proficient Rx LP	Teva Pharmaceuticals USA, Inc.	Virtus Pharmaceuticals	Mylan Pharmaceuticals Inc.	Aurobindo Pharma Limited	NorthStar Rx LLC	Preferred Pharmaceuticals, Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE K30(U725QWY32X)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Alendronate Sodium