Pamidronate Disodium

NDA 21113, held by Hikma. Pamidronate Disodium.

As of Nov 15, 2026, NDA 21113 (Pamidronate Disodium), held by Hikma, was first approved by FDA on Mar 4, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 4, 2002
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 4, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Label Review

Products

2 strengths and forms


Pamidronate Disodium30MG/10ML (3MG/ML) · injectable;injection	Pamidronate Disodium	RxReference drug
Pamidronate Disodium90MG/10ML (9MG/ML) · injectable;injection	Pamidronate Disodium	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


May 22, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 4, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 18, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 27, 2009	Supplement 8Labeling · Standard review	Approved	Letter Label
Oct 17, 2008	Supplement 6Labeling · Standard review	Approved	Letter
Nov 14, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
Sep 29, 2004	Supplement 2Manufacturing · Standard review	Approved	Letter
Mar 4, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21113
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