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FDA ANDA · ANDA040766

HYDROXYCHLOROQUINE SULFATE

Sponsor: IPCA LABS LTD

APPLICATION
ANDA040766
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-14
LATEST ACTION
2024-01-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

Approval history

2024-01-24Labeling · Supplement 24 · standardAP
2024-01-24Labeling · Supplement 27 · standardAP
2022-11-10Labeling · Supplement 21 · standardAP
2022-11-10Labeling · Supplement 20 · standardAP
2021-08-23Labeling · Supplement 18 · standardAP
2020-03-31Labeling · Supplement 13 · standard — Label ↗AP
2008-02-20Labeling · Supplement 2AP
2007-06-14OriginalAP
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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