Chloroquine phosphate
Chloroquine phosphate: 1 brand, 13 generics; first approved Jan 13, 1982; generic available.
Generic available: 13 ANDA applications approved.
Brand (NDA) products
- ARALENRLDSANOFI AVENTIS USNDA 006002—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
- CHLOROQUINE PHOSPHATESUVEN PHARMSANDA 2147562021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA - CHLOROQUINE PHOSPHATERSNATCO PHARMA LTDANDA 0916212011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AA - CHLOROQUINE PHOSPHATERSNATCO PHARMA LTDANDA 0906122011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA - CHLOROQUINE PHOSPHATEIPCA LABS LTDANDA 0906102009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEIPCA LABS LTDANDA 0902492009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEIMPAX LABSANDA 0405162003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA - CHLOROQUINE PHOSPHATEWATSON LABSANDA 0879791982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEWATSON LABSANDA 0880301982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATETEVAANDA 0875041982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEHIKMA PHARMSANDA 083082—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEIMPAX LABSANDA 080880—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AA - CHLOROQUINE PHOSPHATEMD PHARMANDA 087228—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - CHLOROQUINE PHOSPHATEPUREPAC PHARMANDA 080886—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1982–2021 across 14 FDA applications.
Chloroquine phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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