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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212469
Company: PADAGIS ISRAEL
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 No
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

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 ASTRAZENECA

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 ASTRAZENECA
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