Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008316
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMAQUINE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/1952 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008316s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008316Orig1s023ltr.pdf
07/27/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008316s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008316Orig1s022ltr.pdf
04/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008316Orig1s021ltr.pdf
07/28/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008316s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008316s017ltr.pdf
06/11/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08316slr015ltr.pdf
10/27/1993 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/29/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/28/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1985 SUPPL-9 Labeling

Label is not available on this site.

10/30/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/10/1986 SUPPL-7 Labeling

Label is not available on this site.

05/15/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1977 SUPPL-5 Labeling

Label is not available on this site.

09/11/1976 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/22/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008316s023lbl.pdf
07/27/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008316s022lbl.pdf
04/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf
07/28/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008316s017lbl.pdf
06/11/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl.pdf

PRIMAQUINE

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRIMAQUINE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription Yes AB 008316 SANOFI AVENTIS US
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 203924 ALVOGEN INC
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 204476 BAYSHORE PHARMS LLC
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 206043 INGENUS PHARMS NJ

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