APPLICATION
ANDA075841
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-27
LATEST ACTION
2020-01-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) · INJECTABLE · INJECTION
Approval history
2020-01-07Labeling · Supplement 19 · standardAP
2009-07-15Labeling · Supplement 16AP
2008-07-09Labeling · Supplement 14AP
2007-01-19Labeling · Supplement 10AP
2006-07-14Labeling · Supplement 9AP
2006-05-19Labeling · Supplement 7AP
2005-01-21Labeling · 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.
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