Aredia

NDA 20036, held by Novartis. Pamidronate Disodium.

As of Nov 14, 2026, NDA 20036 (Aredia), held by Novartis, was first approved by FDA on Oct 31, 1991, with 32 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1991
Review: Priority
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below


Jul 12, 2002	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter
Aug 20, 2001	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Jul 16, 1996	Supplement 11Efficacy (new indication or use) · Priority review	Approved	None posted
Sep 1, 1995	Supplement 9Efficacy (new indication or use) · Priority review	Approved	None posted
Sep 21, 1994	Supplement 7Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 15, 1994	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Review Label
Oct 31, 1991	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

3 strengths and forms


Aredia30MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Pamidronate Disodium	DiscontinuedReference drug
Aredia60MG/VIAL · injectable;injection	Pamidronate Disodium	Discontinued
Aredia90MG/VIAL · injectable;injection	Pamidronate Disodium	Discontinued

All 33 submissions, including labeling and manufacturing supplements


May 31, 2012	Supplement 41Labeling · Priority review	Approved	Letter Label
Apr 7, 2011	Supplement 39Labeling · Priority review	Approved	Label Letter
Dec 12, 2008	Supplement 35Labeling · Priority review	Approved	Label Letter
Dec 11, 2007	Supplement 34Labeling · Priority review	Approved	Letter Label
Nov 16, 2005	Supplement 32Labeling · Priority review	Approved	Letter Label
Oct 11, 2005	Supplement 31Labeling · Priority review	Approved	Letter Label
Feb 2, 2005	Supplement 30Labeling · Priority review	Approved	Review Letter Label
Mar 24, 2004	Supplement 29Labeling · Priority review	Approved	Letter
Jan 9, 2004	Supplement 28Labeling · Priority review	Approved	Review Letter
Oct 9, 2003	Supplement 20Labeling · Priority review	Approved	Review Letter
Jul 12, 2002	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter
Feb 12, 2002	Supplement 25Manufacturing · Priority review	Approved	None posted
Jan 3, 2002	Supplement 22Manufacturing · Priority review	Approved	None posted
Nov 15, 2001	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 20, 2001	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Mar 7, 2001	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 28, 2000	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 31, 2000	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 5, 1998	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 22, 1998	Supplement 15Labeling · Priority review	Approved	Letter Review
Sep 22, 1998	Supplement 16Labeling · Priority review	Approved	Letter Review
Sep 10, 1998	Supplement 14Manufacturing · Priority review	Approved	None posted
Jul 16, 1996	Supplement 11Efficacy (new indication or use) · Priority review	Approved	None posted
Sep 1, 1995	Supplement 9Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 17, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Dec 8, 1994	Supplement 8Manufacturing · Priority review	Approved	None posted
Sep 21, 1994	Supplement 7Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 15, 1994	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Review Label
Jun 9, 1993	Supplement 5Labeling · Priority review	Approved	Review
May 6, 1993	Supplement 1Manufacturing · Priority review	Approved	Review
May 6, 1993	Supplement 2Manufacturing · Priority review	Approved	Review
Jul 21, 1992	Supplement 3Labeling · Priority review	Approved	Review
Oct 31, 1991	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 20036
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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