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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, Macleods Pharms Ltd, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Aurobindo Pharma Ltd, and is included in eight 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: 203533

Macleods Pharms Ltd
risedronate sodium
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203533


Suppliers and Packaging for NDA: 203533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
risedronate sodium
TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 33342-107-06 3 BLISTER PACK in 1 CARTON (33342-107-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK
risedronate sodium
TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 33342-107-07 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07)

Summary for product number 001

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

Summary for product number 002

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

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