APPLICATION
ANDA077433
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-26
LATEST ACTION
2016-11-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 60MG/VIAL · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 90MG/VIAL · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 30MG/VIAL · INJECTABLE · INJECTION
Approval history
2016-11-29Labeling · Supplement 2AP
2016-11-29Labeling · Supplement 3AP
2008-11-26OriginalAP
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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