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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 As 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 seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for NDA: 022430

Ferring Pharms As
tranexamic acid
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders

Pharmacology for NDA: 022430

Physiological EffectDecreased Fibrinolysis

Suppliers and Packaging for NDA: 022430

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tranexamic acid
TABLET;ORAL 022430 NDA Ferring Pharmaceuticals Inc. 55566-2110 55566-2110-2 30 TABLET in 1 BOTTLE (55566-2110-2)
tranexamic acid
TABLET;ORAL 022430 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-090 66993-090-30 30 TABLET in 1 BOTTLE (66993-090-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength650MG
Approval Date:Nov 13, 2009TE:ABRLD:Yes
Patent:7,947,739Patent Expiration:Mar 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:9,060,939Patent Expiration:Mar 4, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,022,106Patent Expiration:Mar 4, 2025Product Flag?Substance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.