Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021450

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ZOMIG (ZOLMITRIPTAN)
2.5MG/SPRAY Marketing Status: Prescription

Active Ingredient: ZOLMITRIPTAN
Proprietary Name: ZOMIG
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 2.5MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021450
Product Number: 003
Approval Date: Sep 16, 2013
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

ZOMIG (ZOLMITRIPTAN)
5MG/SPRAY Marketing Status: Prescription

Active Ingredient: ZOLMITRIPTAN
Proprietary Name: ZOMIG
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 5MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021450
Product Number: 004
Approval Date: Sep 30, 2003
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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