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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 022430


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NDA 022430 describes LYSTEDA, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LYSTEDA profile page.

The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 022430
Tradename:LYSTEDA
Applicant:Ferring Pharms Inc
Ingredient:tranexamic acid
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 022430
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 022430
Suppliers and Packaging for NDA: 022430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYSTEDA tranexamic acid TABLET;ORAL 022430 NDA Ferring Pharmaceuticals Inc. 55566-2110 55566-2110-2 30 TABLET in 1 BOTTLE (55566-2110-2)
LYSTEDA tranexamic acid TABLET;ORAL 022430 NDA AUTHORIZED GENERIC Amring Pharmaceuticals, Inc. 69918-301 69918-301-30 30 TABLET in 1 BOTTLE (69918-301-30)
Paragraph IV (Patent) Challenges for 022430
Tradename Dosage Ingredient NDA Submissiondate
LYSTEDA TABLET;ORAL tranexamic acid 022430 2011-05-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength650MG
Approval Date:Nov 13, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 4, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Patent:  Start TrialPatent Expiration:Mar 4, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

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