You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022430


✉ Email this page to a colleague

« Back to Dashboard


NDA 022430 describes LYSTEDA, which is a drug marketed by Amring Pharms and is included in one NDA. It is available from four 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. Thirty-four suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 022430
Tradename:LYSTEDA
Applicant:Amring Pharms
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 AUTHORIZED GENERIC AvPAK 50268-772 50268-772-13 30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)
LYSTEDA tranexamic acid TABLET;ORAL 022430 NDA Amring Pharmaceuticals Inc. 69918-300 69918-300-30 30 TABLET in 1 BOTTLE (69918-300-30)

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.