Details for New Drug Application (NDA): 022430
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The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Thirty-five 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 Effect | Decreased 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: | RX | Dosage: | TABLET;ORAL | Strength | 650MG | ||||
Approval Date: | Nov 13, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 4, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 4, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 4, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING |
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