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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021231
Company: ASTRAZENECA

Other Important Information from FDA

Products on NDA 021231

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21231ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2018	SUPPL-14	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
09/14/2012	SUPPL-11	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-10	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-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021231s009ltr.pdf
01/08/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf
05/21/2003	SUPPL-4	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-3	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/2002/021231_S003_ZOMIG_TABLETS.pdf
12/04/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/17/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021231

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf
09/14/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
09/14/2012	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
08/11/2010	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf
02/13/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf

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