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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006002
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARALEN CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
ARALEN HYDROCHLORIDE CHLOROQUINE HYDROCHLORIDE EQ 40MG BASE/ML INJECTABLE;INJECTION 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
10/31/1949 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2018 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006002s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006002Orig1s045ltr.pdf
07/13/2017 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006002s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/006002Orig1s044ltr.pdf
11/06/2013 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006002Orig1s043ltr.pdf
06/12/2009 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/006002s042ltr.pdf
04/30/2002 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
06/13/2003 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06002slr039ltr.pdf
05/09/2001 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.
10/11/1995 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.
06/23/1992 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/11/1992 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
05/17/1991 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
02/18/1993 SUPPL-32 Labeling

Label is not available on this site.
07/13/1990 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
06/09/1989 SUPPL-30 Labeling

Label is not available on this site.
06/18/1987 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
03/27/1987 SUPPL-27 Labeling

Label is not available on this site.
05/14/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
11/14/1986 SUPPL-25 Labeling

Label is not available on this site.
10/14/1986 SUPPL-24 Labeling

Label is not available on this site.
05/15/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/15/1981 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/08/1980 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
01/08/1980 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/22/1978 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
04/12/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/31/1976 SUPPL-16 Labeling

Label is not available on this site.
01/29/1975 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/24/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006002s045lbl.pdf
07/13/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/006002s044lbl.pdf
11/06/2013 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf
06/13/2003 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf
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