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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075800

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NDA 075800 describes ETIDRONATE DISODIUM, which is a drug marketed by Mylan and is included in one NDA. It is available from two suppliers. Additional details are available on the ETIDRONATE DISODIUM profile page.

The generic ingredient in ETIDRONATE DISODIUM is etidronate disodium. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the etidronate disodium profile page.
Summary for 075800
Ingredient:etidronate disodium
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075800
Suppliers and Packaging for NDA: 075800
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETIDRONATE DISODIUM etidronate disodium TABLET;ORAL 075800 ANDA Mylan Pharmaceuticals Inc. 0378-3286 N 0378-3286-91
ETIDRONATE DISODIUM etidronate disodium TABLET;ORAL 075800 ANDA Mylan Pharmaceuticals Inc. 0378-3288 N 0378-3288-91

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 24, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jan 24, 2003TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Argus Health

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