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FDA NDA · NDA021113

PAMIDRONATE DISODIUM

Sponsor: HIKMA

APPLICATION
NDA021113
TYPE
NDA
ORIGINAL APPROVAL
2002-03-04
LATEST ACTION
2025-05-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PAMIDRONATE DISODIUM · ReferencePrescription
PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUM · ReferencePrescription
PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) · INJECTABLE · INJECTION

Approval history

2025-05-22Labeling · Supplement 18 · standard — Letter ↗AP
2014-12-04Labeling · Supplement 17 · standard — Letter ↗AP
2012-10-18Labeling · Supplement 12 · standard — Letter ↗AP
2009-07-27Labeling · Supplement 8 · standard — Letter ↗AP
2008-10-17Labeling · Supplement 6 · standard — Letter ↗AP
2005-11-14Labeling · Supplement 4 · standard — Label ↗AP
2004-09-29Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2002-03-04Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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