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Details for New Drug Application (NDA): 200477

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NDA 200477 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. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.

Summary for NDA: 200477

Tradename:
RISEDRONATE SODIUM
Applicant:
Mylan Pharms Inc
Ingredient:
risedronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200477

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 200477

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL 200477 ANDA Mylan Pharmaceuticals Inc. 0378-4044 0378-4044-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4044-93)
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL 200477 ANDA Mylan Pharmaceuticals Inc. 0378-4114 0378-4114-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4114-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 30, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Nov 30, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Nov 30, 2015TE:ABRLD:No


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