Pamidronate Disodium

ANDA 78942, held by Am Regent. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 78942 (Pamidronate Disodium), held by Am Regent, was first approved by FDA on Jul 25, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 25, 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
Jul 25, 2008	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 3 submissions, including labeling and manufacturing supplements


Oct 30, 2015	Supplement 5Labeling · Standard review	Approved	None posted
May 17, 2012	Supplement 3Labeling	Approved	None posted
Jul 25, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78942
Drugs@FDA: Overview at FDA
Company: Am Regent

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