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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 077132


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NDA 077132 describes RISEDRONATE SODIUM, which is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Norvium Bioscience, and Orbion Pharms, and is included in fourteen NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 077132
Tradename:RISEDRONATE SODIUM
Applicant:Teva Pharms Usa
Ingredient:risedronate sodium
Patents:0
Pharmacology for NDA: 077132
Medical Subject Heading (MeSH) Categories for 077132
Suppliers and Packaging for NDA: 077132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132 ANDA Teva Pharmaceuticals USA, Inc. 0093-3098 0093-3098-29 12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19)
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 077132 ANDA Teva Pharmaceuticals USA, Inc. 0093-3098 0093-3098-44 4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 5, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Oct 5, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Oct 5, 2007TE:ABRLD:No

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