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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020605
Company: SANDOZ

Other Important Information from FDA

Products on NDA 020605

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/1997	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020605ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s038,020605s022,020781s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020103Orig1s038,020605Orig1s022,020781Orig1s022ltr.pdf
04/29/2021	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s037,020605s021,020781s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/20103s037,20605s021,20781s021ltr.pdf
10/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020103Orig1s036,020605Orig1s020,020781Orig1s020ltr.pdf
11/09/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s035,020605Orig1s019,020781Orig1s019ltr.pdf
09/18/2014	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf
09/28/2016	SUPPL-17	Labeling-Package Insert, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf
12/10/2013	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf
09/14/2011	SUPPL-14	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf
09/22/2010	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf
08/22/2006	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf
12/27/2005	SUPPL-8	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020605_s008_Zofran Tabs.pdf
11/24/2004	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf
12/13/2000	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF
04/11/2000	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020605_S004_ZOFRAN.pdf
01/26/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/15/1997	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020605

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s038,020605s022,020781s022lbl.pdf
04/29/2021	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s037,020605s021,020781s021lbl.pdf
10/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020103s036,020605s020,020781s020lbl.pdf
11/09/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf
09/18/2014	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf
12/10/2013	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf
09/14/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf
09/14/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf
09/22/2010	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf
08/22/2006	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf
12/27/2005	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf
11/24/2004	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf
12/13/2000	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF

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