FDA ANDA · ANDA040274

HYDROXYCHLOROQUINE SULFATE

Sponsor: AUROBINDO PHARMA USA

APPLICATION

ANDA040274

TYPE

ANDA

ORIGINAL APPROVAL

1998-05-29

LATEST ACTION

2024-10-11

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

HYDROXYCHLOROQUINE SULFATEPrescription

HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

2024-10-11Labeling · Supplement 24 · standardAP

2022-07-11Labeling · Supplement 20 · standardAP

2021-08-23Labeling · Supplement 18 · standardAP

2020-04-09Labeling · Supplement 15 · standardAP

2020-04-01Labeling · Supplement 13 · standard — Label ↗AP

2015-01-20Labeling · Supplement 10 · standardAP

2002-09-10Labeling · Supplement 1AP

1998-05-29Original — Review ↗AP

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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