Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021450
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOMIG ZOLMITRIPTAN 2.5MG/SPRAY SPRAY;NASAL Prescription None Yes No
ZOMIG ZOLMITRIPTAN 5MG/SPRAY SPRAY;NASAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/30/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21450_zomig_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21450ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-450_Zomig.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-10 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
06/12/2015 SUPPL-8 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021450s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021450Orig1s008ltr.pdf
09/16/2013 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021450s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021450Orig1s007ltr.pdf
10/14/2008 SUPPL-5 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021450s005ltr.pdf
07/02/2004 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21450slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf
06/12/2015 SUPPL-8 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021450s008lbl.pdf
09/16/2013 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021450s007lbl.pdf
09/30/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21450_zomig_lbl.pdf

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