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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083082
Company: HIKMA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None No No
CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/09/1975 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/24/2023 SUPPL-59 Labeling-Package Insert

Label is not available on this site.
05/03/2022 SUPPL-58 Labeling-Package Insert

Label is not available on this site.
03/17/2022 SUPPL-57 Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-56 Labeling-Package Insert

Label is not available on this site.
11/10/2009 SUPPL-50 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf
05/31/2007 SUPPL-49 Labeling

Label is not available on this site.
03/21/2006 SUPPL-48 Labeling

Label is not available on this site.
09/29/2005 SUPPL-47 Labeling

Label is not available on this site.
07/11/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
11/30/2000 SUPPL-40 Labeling

Label is not available on this site.
11/30/2000 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/30/2000 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/24/2000 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/24/2000 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.
05/24/2000 SUPPL-35 Labeling

Label is not available on this site.
09/17/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
09/17/1999 SUPPL-33 Labeling

Label is not available on this site.
09/17/1999 SUPPL-32 Manufacturing (CMC)-New Strength

Label is not available on this site.
05/24/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
05/24/2000 SUPPL-30 Labeling

Label is not available on this site.
05/24/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
10/01/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
09/05/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
04/02/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
07/20/1989 SUPPL-21 Bioequivalence

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/10/2009 SUPPL-50 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf
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