Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020626

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IMITREX (SUMATRIPTAN)
5MG/SPRAY
Marketing Status: Prescription

Active Ingredient: SUMATRIPTAN
Proprietary Name: IMITREX
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 5MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020626
Product Number: 001
Approval Date: Aug 26, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

IMITREX (SUMATRIPTAN)
20MG/SPRAY
Marketing Status: Prescription

Active Ingredient: SUMATRIPTAN
Proprietary Name: IMITREX
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 20MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020626
Product Number: 003
Approval Date: Aug 26, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

IMITREX (SUMATRIPTAN)
10MG/SPRAY
Marketing Status: Discontinued

Active Ingredient: SUMATRIPTAN
Proprietary Name: IMITREX
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 10MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020626
Product Number: 002
Approval Date: Aug 26, 1997
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information