APPLICATION
ANDA078373
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-23
LATEST ACTION
2019-11-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) · INJECTABLE · INJECTION
Approval history
2019-11-22Labeling · Supplement 5 · standardAP
2010-03-15Labeling · Supplement 4AP
2009-02-24Labeling · Supplement 1AP
2008-12-23OriginalAP
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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