Pamidronate Disodium

ANDA 76207, held by Fresenius Kabi USA. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 76207 (Pamidronate Disodium), held by Fresenius Kabi USA, was first approved by FDA on May 17, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: May 17, 2002
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
May 17, 2002	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Jul 2, 2015	Supplement 13Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 11Labeling	Approved	None posted
Sep 18, 2008	Supplement 7Labeling	Approved	None posted
Feb 23, 2007	Supplement 6Labeling	Approved	None posted
Nov 29, 2005	Supplement 4Labeling	Approved	None posted
Jan 21, 2005	Supplement 3Labeling	Approved	None posted
Feb 13, 2004	Supplement 1Labeling	Approved	None posted
May 17, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76207
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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