Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021001

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AXERT (ALMOTRIPTAN MALATE)
EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ALMOTRIPTAN MALATE
Proprietary Name: AXERT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021001
Product Number: 001
Approval Date: May 7, 2001
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AXERT (ALMOTRIPTAN MALATE)
EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ALMOTRIPTAN MALATE
Proprietary Name: AXERT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021001
Product Number: 002
Approval Date: May 7, 2001
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information