Details for New Drug Application (NDA): 022430
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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-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid 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: | 8 |
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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