← FDA DRUG APPROVALS

FDA NDA · NDA020036

AREDIA

Sponsor: NOVARTIS

APPLICATION
NDA020036
TYPE
NDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2012-05-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AREDIADiscontinued
PAMIDRONATE DISODIUM 90MG/VIAL · INJECTABLE · INJECTION
AREDIADiscontinued
PAMIDRONATE DISODIUM 60MG/VIAL · INJECTABLE · INJECTION
AREDIA · ReferenceDiscontinued
PAMIDRONATE DISODIUM 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2012-05-31Labeling · Supplement 41 · priority — Label ↗AP
2011-04-07Labeling · Supplement 39 · priority — Letter ↗AP
2008-12-12Labeling · Supplement 35 · priority — Label ↗AP
2007-12-11Labeling · Supplement 34 · priority — Label ↗AP
2005-11-16Labeling · Supplement 32 · priority — Label ↗AP
2005-10-11Labeling · Supplement 31 · priority — Label ↗AP
2005-02-02Labeling · Supplement 30 · priority — Review ↗AP
2004-03-24Labeling · Supplement 29 · priority — Letter ↗AP
2004-01-09Labeling · Supplement 28 · priority — Review ↗AP
2003-10-09Labeling · Supplement 20 · priority — Review ↗AP
2002-07-12Efficacy · Supplement 26 · priority — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 25 · priorityAP
2002-01-03Manufacturing (CMC) · Supplement 22 · priorityAP
2001-11-15Manufacturing (CMC) · Supplement 23 · priorityAP
2001-08-20Efficacy · Supplement 24 · priority — Label ↗AP
2001-03-07Manufacturing (CMC) · Supplement 21 · priorityAP
2000-04-28Manufacturing (CMC) · Supplement 18 · priorityAP
2000-03-31Manufacturing (CMC) · Supplement 19 · priorityAP
1998-10-05Manufacturing (CMC) · Supplement 13 · priorityAP
1998-09-22Labeling · Supplement 15 · priority — Review ↗AP
1998-09-22Labeling · Supplement 16 · priority — Review ↗AP
1998-09-10Manufacturing (CMC) · Supplement 14 · priorityAP
1996-07-16Efficacy · Supplement 11 · priorityAP
1995-09-01Efficacy · Supplement 9 · priorityAP
1995-04-17Manufacturing (CMC) · Supplement 6 · priorityAP
1994-12-08Manufacturing (CMC) · Supplement 8 · priorityAP
1994-09-21Efficacy · Supplement 7 · priorityAP
1994-04-15Efficacy · Supplement 4 · priority — Letter ↗AP
1993-06-09Labeling · Supplement 5 · priority — Review ↗AP
1993-05-06Manufacturing (CMC) · Supplement 2 · priority — Review ↗AP
1993-05-06Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
1992-07-21Labeling · Supplement 3 · priority — Review ↗AP
1991-10-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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