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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021450
Company: AMNEAL

Other Important Information from FDA

Products on NDA 021450

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOMIG	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY;NASAL	Prescription	AB	Yes	No
ZOMIG	ZOLMITRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021450

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

Labels for NDA 021450

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

Therapeutic Equivalents for NDA 021450

ZOMIG

SPRAY;NASAL; 2.5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	212469	PADAGIS ISRAEL
ZOMIG	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	021450	AMNEAL

SPRAY;NASAL; 5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLMITRIPTAN	ZOLMITRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	212469	PADAGIS ISRAEL
ZOMIG	ZOLMITRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	021450	AMNEAL

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