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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020403
Company: GLAXOSMITHKLINE

Products on NDA 020403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ONDANSETRON HYDROCHLORIDE	EQ 0.64MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/1995	ORIG-1	Approval	Type 3 - New Dosage Form	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
09/14/2011	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf
07/07/2011	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf
09/22/2010	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf
08/22/2006	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf
12/27/2005	SUPPL-14	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020403s014rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020403_s014_Zofran Inj.pdf
11/24/2004	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf
11/15/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/2000	SUPPL-11	Labeling		Label is not available on this site.
12/08/2000	SUPPL-10	Labeling		Label is not available on this site.
04/11/2000	SUPPL-9	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020403_s009_ZOFRAN_INJECTION.pdf
02/17/1999	SUPPL-8	Labeling		Label is not available on this site.
03/10/1999	SUPPL-7	Labeling		Label is not available on this site.
10/31/1997	SUPPL-5	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm
04/02/1997	SUPPL-4	Labeling		Label is not available on this site.
03/12/1996	SUPPL-3	Labeling		Label is not available on this site.
07/26/1996	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/24/1996	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020403

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2011	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf
07/07/2011	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf
09/22/2010	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf
08/22/2006	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf
12/27/2005	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf
11/24/2004	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf

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