APPLICATION
ANDA075290
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-30
LATEST ACTION
2012-11-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 90MG/VIAL · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 30MG/VIAL · INJECTABLE · INJECTION
Approval history
2012-11-08Labeling · Supplement 20 · standardAP
2012-05-17Labeling · Supplement 18AP
2009-09-09Labeling · Supplement 14AP
2008-07-24Labeling · Supplement 11AP
2007-09-23Labeling · Supplement 10AP
2005-07-19Labeling · Supplement 8AP
2005-05-11Labeling · Supplement 6AP
2004-05-18Labeling · Supplement 4AP
2002-11-07Manufacturing (CMC) · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.