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FDA ANDA · ANDA078156

PAMIDRONATE DISODIUM

Sponsor: DR REDDYS

APPLICATION
ANDA078156
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-19
LATEST ACTION
2022-08-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) · INJECTABLE · INJECTION
PAMIDRONATE DISODIUMPrescription
PAMIDRONATE DISODIUM 60MG/10ML (6MG/ML) · INJECTABLE · INJECTION

Approval history

2022-08-01Labeling · Supplement 2 · standardAP
2009-10-16Labeling · Supplement 1AP
2008-08-19Original — 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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