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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203217

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NDA 203217 describes RISEDRONATE SODIUM, which is a drug marketed by Teva Pharms Usa, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Apotex Inc, 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 NDA: 203217

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203217

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 203217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM
risedronate sodium
TABLET, DELAYED RELEASE;ORAL 203217 ANDA Teva Pharmaceuticals USA Inc 0093-5509 0093-5509-44 4 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-5509-44) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0093-5509-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength35MG
Approval Date:May 18, 2015TE:ABRLD:No


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