Pamidronate Disodium

ANDA 78373, held by Sagent Pharms Inc. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 78373 (Pamidronate Disodium), held by Sagent Pharms Inc, was first approved by FDA on Dec 23, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 23, 2008	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Nov 22, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Mar 15, 2010	Supplement 4Labeling	Approved	None posted
Feb 24, 2009	Supplement 1Labeling	Approved	None posted
Dec 23, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78373
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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