APPLICATION
ANDA083082
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-09
LATEST ACTION
2023-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLOROQUINE PHOSPHATEDiscontinued
CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CHLOROQUINE PHOSPHATEDiscontinued
CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2023-07-24Labeling · Supplement 59 · standardAP
2022-05-03Labeling · Supplement 58 · standardAP
2022-03-17Labeling · Supplement 57 · standardAP
2020-05-29Labeling · Supplement 56 · standardAP
2007-05-31Labeling · Supplement 49AP
2006-03-21Labeling · Supplement 48AP
2005-09-29Labeling · Supplement 47AP
2001-07-11Manufacturing (CMC) · Supplement 41AP
2000-11-30Manufacturing (CMC) · Supplement 38AP
2000-11-30Labeling · Supplement 40AP
2000-11-30Manufacturing (CMC) · Supplement 39AP
2000-05-24Manufacturing (CMC) · Supplement 36AP
2000-05-24Labeling · Supplement 30AP
2000-05-24Manufacturing (CMC) · Supplement 37AP
2000-05-24Manufacturing (CMC) · Supplement 29AP
2000-05-24Labeling · Supplement 35AP
2000-05-24Manufacturing (CMC) · Supplement 31AP
1999-09-17Manufacturing (CMC) · Supplement 34AP
1999-09-17Manufacturing (CMC) · Supplement 32AP
1999-09-17Labeling · Supplement 33AP
1998-10-01Manufacturing (CMC) · Supplement 28AP
1997-09-05Manufacturing (CMC) · Supplement 26AP
1997-09-05Manufacturing (CMC) · Supplement 24AP
1997-09-05Manufacturing (CMC) · Supplement 27AP
1997-09-05Manufacturing (CMC) · Supplement 25AP
1997-09-05Manufacturing (CMC) · Supplement 23AP
1991-04-02Manufacturing (CMC) · Supplement 22AP
1989-07-20Bioequivalence · Supplement 21AP
1975-07-09OriginalAP
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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