Risedronate Sodium

ANDA 200477, held by Pharmobedient. Risedronate Sodium.

As of Nov 15, 2026, ANDA 200477 (Risedronate Sodium), held by Pharmobedient, was first approved by FDA on Nov 30, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 30, 2015
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Nov 30, 2015	Original application	Approved	None posted
Jun 10, 2014	Original application	Approved	None posted

Products

5 strengths and forms


Risedronate Sodium5MG · tablet;oral	Risedronate Sodium	Discontinued
Risedronate Sodium30MG · tablet;oral	Risedronate Sodium	Discontinued
Risedronate Sodium35MG · tablet;oral	Risedronate Sodium	Discontinued
Risedronate Sodium75MG · tablet;oral	Risedronate Sodium	Discontinued
Risedronate Sodium150MG · tablet;oral	Risedronate Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 30, 2015	Original application	Approved	None posted
Nov 17, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jun 10, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 200477
Drugs@FDA: Overview at FDA
Company: PharmoBedient

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters