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FDA ANDA · ANDA210959

HYDROXYCHLOROQUINE SULFATE

Sponsor: LAURUS

APPLICATION
ANDA210959
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-15
LATEST ACTION
2024-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

Approval history

2024-02-01Labeling · Supplement 15 · standardAP
2024-01-08Labeling · Supplement 14 · standardAP
2023-07-12Labeling · Supplement 12 · standardAP
2023-07-12Labeling · Supplement 10 · standardAP
2023-03-06Manufacturing (CMC) · Supplement 13 · unknownAP
2020-04-01Labeling · Supplement 5 · standard — Letter ↗AP
2020-04-01Labeling · Supplement 1 · standard — Letter ↗AP
2019-01-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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