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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008316
Company: SANOFI AVENTIS US

Products on NDA 008316

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008316

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.

Labels for NDA 008316

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

Therapeutic Equivalents for NDA 008316

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	206043	NOVAST LABS
PRIMAQUINE PHOSPHATE	PRIMAQUINE PHOSPHATE	EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	204476	UNICHEM

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