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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020768
Company: IPR

Other Important Information from FDA

Products on NDA 020768

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOMIG	ZOLMITRIPTAN	2.5MG	TABLET;ORAL	Discontinued	None	Yes	No
ZOMIG	ZOLMITRIPTAN	5MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020768_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2018	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020768Orig1s023,021231Orig1s014,021450Orig1s010Ltr.pdf
03/12/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/14/2012	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
09/14/2012	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
08/11/2010	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf
01/08/2004	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf
11/16/2004	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf
05/21/2003	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf
10/09/2002	SUPPL-10	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020768_S010_ZOMIG_TABLETS.pdf
12/18/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/12/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/09/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/29/2002	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768s6ltr.pdf
02/14/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/29/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/01/2000	SUPPL-3	Labeling		Label is not available on this site.
02/16/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020768

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf
09/14/2012	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
09/14/2012	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
08/11/2010	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf
11/16/2004	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf

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