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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203533

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NDA 203533 describes RISEDRONATE SODIUM, which is a drug marketed by Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the RISEDRONATE SODIUM profile page.

The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 203533
Tradename:RISEDRONATE SODIUM
Applicant:Macleods Pharms Ltd
Ingredient:risedronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203533
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 203533
Suppliers and Packaging for NDA: 203533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 N 33342-107-06
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 N 33342-107-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 9, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Dec 9, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Nov 29, 2016TE:ABRLD:No

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