APPLICATION
NDA006002
TYPE
NDA
ORIGINAL APPROVAL
1949-10-31
LATEST ACTION
2018-10-24
ROUTE
ORAL, INJECTION
DOSAGE FORM
TABLET, INJECTABLE
MARKETING STATUS
Discontinued
Products
ARALEN · ReferenceDiscontinued
CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ARALEN HYDROCHLORIDEDiscontinued
CHLOROQUINE HYDROCHLORIDE EQ 40MG BASE/ML · INJECTABLE · INJECTION
Approval history
2002-04-30Manufacturing (CMC) · Supplement 40AP
2001-05-09Manufacturing (CMC) · Supplement 38AP
1995-10-11Manufacturing (CMC) · Supplement 37AP
1993-02-18Labeling · Supplement 32AP
1992-06-23Manufacturing (CMC) · Supplement 35AP
1992-03-11Manufacturing (CMC) · Supplement 34AP
1991-05-17Manufacturing (CMC) · Supplement 33AP
1990-07-13Manufacturing (CMC) · Supplement 31AP
1989-06-09Labeling · Supplement 30AP
1987-06-18Manufacturing (CMC) · Supplement 28AP
1987-03-27Labeling · Supplement 27AP
1986-11-14Labeling · Supplement 25AP
1986-10-14Labeling · Supplement 24AP
1982-05-14Manufacturing (CMC) · Supplement 26AP
1981-05-15Manufacturing (CMC) · Supplement 22AP
1981-05-15Manufacturing (CMC) · Supplement 23AP
1980-08-08Manufacturing (CMC) · Supplement 21AP
1980-01-08Manufacturing (CMC) · Supplement 20AP
1978-05-22Manufacturing (CMC) · Supplement 18AP
1976-04-12Manufacturing (CMC) · Supplement 17AP
1976-03-31Labeling · Supplement 16AP
1975-01-29Manufacturing (CMC) · Supplement 15AP
1949-10-31UNKNOWN · Original · unknownAP
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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