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FDA Orange Book · active-ingredient family

Chloroquine phosphate

Chloroquine phosphate is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARALEN · NDA 006002

1

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ARALENRLDSANOFI AVENTIS USNDA 006002—Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
CHLOROQUINE PHOSPHATESUVEN PHARMSANDA 214756AASep 03, 2021
CHLOROQUINE PHOSPHATENATCO PHARMA LTDANDA 091621AAJan 21, 2011
CHLOROQUINE PHOSPHATENATCO PHARMA LTDANDA 090612AAJan 21, 2011
CHLOROQUINE PHOSPHATEIPCA LABS LTDANDA 090610—Dec 03, 2009
CHLOROQUINE PHOSPHATEIPCA LABS LTDANDA 090249—Dec 03, 2009
CHLOROQUINE PHOSPHATEIMPAX LABSANDA 040516AAAug 29, 2003
CHLOROQUINE PHOSPHATEWATSON LABSANDA 087979—Dec 21, 1982
CHLOROQUINE PHOSPHATEWATSON LABSANDA 088030—Dec 21, 1982
CHLOROQUINE PHOSPHATETEVAANDA 087504—Jan 13, 1982
CHLOROQUINE PHOSPHATE×2HIKMA PHARMSANDA 083082—Approved Prior to Jan 1, 1982
CHLOROQUINE PHOSPHATEIMPAX LABSANDA 080880AAApproved Prior to Jan 1, 1982
CHLOROQUINE PHOSPHATEMD PHARMANDA 087228—Approved Prior to Jan 1, 1982
CHLOROQUINE PHOSPHATEPUREPAC PHARMANDA 080886—Approved Prior to Jan 1, 1982

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.

Chloroquine phosphate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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