Details for New Drug Application (NDA): 217933
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NDA 217933 describes AURLUMYN, which is a drug marketed by Btg Intl and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the AURLUMYN profile page.
The generic ingredient in AURLUMYN is iloprost. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.
The generic ingredient in AURLUMYN is iloprost. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.
Suppliers and Packaging for NDA: 217933
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AURLUMYN | iloprost | SOLUTION;INTRAVENOUS | 217933 | NDA | BTG International Inc | 50633-340 | 50633-340-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MCG/ML (100MCG/ML) | ||||
| Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Feb 13, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 18, 2044 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS | ||||||||
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