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FDA Drug information

Risedronate Sodium

Read time: 1 mins
Marketing start date: 14 Nov 2024
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Summary of product characteristics


Effective Time

20230927

Version

5

Spl Product Data Elements

Risedronate Sodium Risedronate Sodium RISEDRONATE SODIUM ANHYDROUS RISEDRONIC ACID EDETATE DISODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POLYSORBATE 80 METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TRIETHYL CITRATE YELLOW ROUND 75

Application Number

ANDA203822

Brand Name

Risedronate Sodium

Generic Name

Risedronate Sodium

Product Ndc

70771-1436

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1436-4 in blister-carton of 4 (1 x 4) Unit-dose Tablets Risedronate Sodium Delayed-release Tablets, 35 mg R x only 4 Tablets Risedronate Sodium DR Tablets, 35 mg Risedronate Sodium DR Tablets, 35 mg Risedronate Sodium DR Tablets, 35 mg

Drug section

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