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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 210708


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NDA 210708 describes ELETRIPTAN HYDROBROMIDE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma, Beximco Pharms Usa, Mylan, Stevens J, Teva Pharms Usa, Yung Shin Pharm, and Zydus Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the ELETRIPTAN HYDROBROMIDE profile page.

The generic ingredient in ELETRIPTAN HYDROBROMIDE is eletriptan hydrobromide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.
Summary for 210708
Tradename:ELETRIPTAN HYDROBROMIDE
Applicant:Aurobindo Pharma
Ingredient:eletriptan hydrobromide
Patents:0
Pharmacology for NDA: 210708
Suppliers and Packaging for NDA: 210708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 210708 ANDA Aurobindo Pharma Limited 59651-104 59651-104-69 1 BLISTER PACK in 1 CARTON (59651-104-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-104-06)
ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 210708 ANDA Aurobindo Pharma Limited 59651-105 59651-105-69 1 BLISTER PACK in 1 CARTON (59651-105-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-105-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jan 15, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Jan 15, 2019TE:ABRLD:No

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