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Last Updated: January 23, 2020

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Details for New Drug Application (NDA): 078027

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NDA 078027 describes ALMOTRIPTAN MALATE, which is a drug marketed by Ajanta Pharma Ltd, Mylan, and Teva Pharms Usa, and is included in three NDAs. It is available from three suppliers. Additional details are available on the ALMOTRIPTAN MALATE profile page.

The generic ingredient in ALMOTRIPTAN MALATE is almotriptan malate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.
Summary for 078027
Tradename:ALMOTRIPTAN MALATE
Applicant:Teva Pharms Usa
Ingredient:almotriptan malate
Patents:0
Pharmacology for NDA: 078027
Suppliers and Packaging for NDA: 078027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 078027 ANDA Teva Pharmaceuticals USA, Inc. 0093-5260 0093-5260-18 6 BLISTER PACK in 1 CARTON (0093-5260-18) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-5260-19)
ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 078027 ANDA Teva Pharmaceuticals USA, Inc. 0093-5261 0093-5261-29 12 BLISTER PACK in 1 CARTON (0093-5261-29) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-5261-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.25MG BASE
Approval Date:Jul 7, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Jul 7, 2015TE:ABRLD:No

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