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FDA ANDA · ANDA217134

IOPAMIDOL

Sponsor: HAINAN POLY

APPLICATION
ANDA217134
TYPE
ANDA
ORIGINAL APPROVAL
2023-09-27
LATEST ACTION
2024-04-09
ROUTE
INTRAVASCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IOPAMIDOLPrescription
IOPAMIDOL 61% · INJECTABLE · INJECTION
IOPAMIDOLPrescription
IOPAMIDOL 41% · INJECTABLE · INJECTION
IOPAMIDOLPrescription
IOPAMIDOL 76% · INJECTABLE · INJECTION
IOPAMIDOLPrescription
IOPAMIDOL 51% · INJECTABLE · INJECTION

Approval history

2024-04-09Manufacturing (CMC) · Supplement 1 · unknownAP
2023-09-27UNKNOWN · Original · standard — Letter ↗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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