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Generated: November 16, 2018

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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 three 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-four 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 Prasco Laboratories 66993-090 66993-090-30 30 TABLET in 1 BOTTLE (66993-090-30)

Profile for product number 001

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

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