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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020316
Company: GUERBET

Products on NDA 020316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXILAN-300	IOXILAN	62%	INJECTABLE;INJECTION	Discontinued	None	No	No
OXILAN-350	IOXILAN	73%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	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
04/05/2017	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020316Orig1s029ltr.pdf
07/06/2015	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020316Orig1s028ltr.pdf
11/12/2006	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020316s021LTR.pdf
01/06/2003	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20316slr016ltr.pdf
08/12/2002	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/17/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/18/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/30/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/04/1999	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/22/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/15/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/17/1997	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020316

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf
07/06/2015	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf

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