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FDA ANDA · ANDA078942

PAMIDRONATE DISODIUM

Sponsor: AM REGENT

APPLICATION
ANDA078942
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-25
LATEST ACTION
2015-10-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-10-30Labeling · Supplement 5 · standardAP
2012-05-17Labeling · Supplement 3AP
2008-07-25Original — Other Important Information from FDA ↗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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