Pamidronate Disodium

ANDA 75290, held by Hikma. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 75290 (Pamidronate Disodium), held by Hikma, was first approved by FDA on Apr 30, 2001, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2001
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 30, 2001	Original application	Approved	Label Letter Review

Products

2 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Nov 8, 2012	Supplement 20Labeling · Standard review	Approved	None posted
May 17, 2012	Supplement 18Labeling	Approved	None posted
Sep 9, 2009	Supplement 14Labeling	Approved	None posted
Jul 24, 2008	Supplement 11Labeling	Approved	None posted
Sep 23, 2007	Supplement 10Labeling	Approved	None posted
Jul 19, 2005	Supplement 8Labeling	Approved	None posted
May 11, 2005	Supplement 6Labeling	Approved	None posted
May 18, 2004	Supplement 4Labeling	Approved	None posted
Nov 7, 2002	Supplement 2Manufacturing	Approved	None posted
Apr 30, 2001	Original application	Approved	Label Letter Review

Identifiers

Application: ANDA 75290
Drugs@FDA: Overview at FDA
Company: Hikma

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