Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212469
Company: PADAGIS ISRAEL

Products on ANDA 212469

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212469

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212469Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212469

ZOLMITRIPTAN

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