Pamidronate Disodium

ANDA 76153, held by Teva Pharms USA. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 76153 (Pamidronate Disodium), held by Teva Pharms USA, was first approved by FDA on Mar 27, 2002, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 27, 2002
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 27, 2002	Original application	Approved	Letter Letter

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 5 submissions, including labeling and manufacturing supplements


Nov 5, 2015	Supplement 28Labeling · Standard review	Approved	None posted
Aug 13, 2012	Supplement 23Labeling · Standard review	Approved	None posted
May 22, 2012	Supplement 21Labeling	Approved	None posted
Mar 19, 2009	Supplement 8Labeling	Approved	None posted
Mar 27, 2002	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 76153
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals 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