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Generated: January 22, 2019

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Details for New Drug Application (NDA): 205523

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NDA 205523 describes ALMOTRIPTAN MALATE, which is a drug marketed by Ajanta Pharma Ltd, Mylan Pharms Inc, 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 205523
Tradename:ALMOTRIPTAN MALATE
Applicant:Ajanta Pharma Ltd
Ingredient:almotriptan malate
Patents:0
Pharmacology for NDA: 205523
Suppliers and Packaging for NDA: 205523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523 ANDA Ajanta Pharma Limited 27241-041 27241-041-11 1 BLISTER PACK in 1 CARTON (27241-041-11) > 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-041-68)
ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523 ANDA Ajanta Pharma Limited 27241-042 27241-042-21 2 BLISTER PACK in 1 CARTON (27241-042-21) > 6 TABLET, FILM COATED in 1 BLISTER PACK (27241-042-68)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.25MG BASE
Approval Date:Mar 3, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Mar 3, 2016TE:ABRLD:No

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