Pamidronate Disodium

ANDA 75773, held by Fresenius Kabi USA. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 75773 (Pamidronate Disodium), held by Fresenius Kabi USA, was first approved by FDA on May 6, 2002, with 1 approved supplement and 0 published complete response letters.

First approved: May 6, 2002
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 6, 2002	Original application	Approved	Review Letter

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Dec 5, 2002	Supplement 1Manufacturing	Approved	None posted
May 6, 2002	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75773
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