Pamidronate Disodium

ANDA 77433, held by Areva Pharms. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 77433 (Pamidronate Disodium), held by Areva Pharms, was first approved by FDA on Nov 26, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 26, 2008	Original application	Approved	None posted

Products

3 strengths and forms


Pamidronate Disodium30MG/VIAL · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium60MG/VIAL · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium90MG/VIAL · injectable;injection	Pamidronate Disodium	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 29, 2016	Supplement 2Labeling	Approved	None posted
Nov 29, 2016	Supplement 3Labeling	Approved	None posted
Nov 26, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77433
Drugs@FDA: Overview at FDA
Company: Areva Pharmaceuticals

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