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FDA ANDA · ANDA076207

PAMIDRONATE DISODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA076207
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-17
LATEST ACTION
2015-07-02
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

2015-07-02Labeling · Supplement 13 · standardAP
2012-05-21Labeling · Supplement 11AP
2008-09-18Labeling · Supplement 7AP
2007-02-23Labeling · Supplement 6AP
2005-11-29Labeling · Supplement 4AP
2005-01-21Labeling · Supplement 3AP
2004-02-13Labeling · Supplement 1AP
2002-05-17Original — 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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