Details for New Drug Application (NDA): 022430

NDA 022430 describes LYSTEDA, which is a drug marketed by Amring Pharms and is included in one NDA. It is available from two suppliers. 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-seven 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:	0

Medical Subject Heading (MeSH) Categories for 022430

Antifibrinolytic Agents

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 AUTHORIZED GENERIC	Nordic Pharma, Inc.	69918-301	69918-301-30	30 TABLET in 1 BOTTLE (69918-301-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	650MG
Approval Date:	Nov 13, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022430

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009

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