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FDA ANDA · ANDA213342

HYDROXYCHLOROQUINE SULFATE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA213342
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-07
LATEST ACTION
2023-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 400MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 100MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 300MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

Approval history

2023-09-12Labeling · Supplement 5 · standardAP
2020-04-07UNKNOWN · Original · standardAP
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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