Pamidronate Disodium

ANDA 78156, held by Dr Reddys. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 78156 (Pamidronate Disodium), held by Dr Reddys, was first approved by FDA on Aug 19, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 19, 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
Aug 19, 2008	Original application	Approved	None posted

Products

3 strengths and forms


Pamidronate Disodium30MG/10ML (3MG/ML) · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium60MG/10ML (6MG/ML) · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium90MG/10ML (9MG/ML) · injectable;injection	Pamidronate Disodium	Rx

All 3 submissions, including labeling and manufacturing supplements


Aug 1, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Oct 16, 2009	Supplement 1Labeling	Approved	None posted
Aug 19, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78156
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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