Details for New Drug Application (NDA): 217933
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The generic ingredient in AURLUMYN is iloprost. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloprost profile page.
Summary for 217933
Tradename: | AURLUMYN |
Applicant: | Eicos Sci |
Ingredient: | iloprost |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | Eicos Sciences Inc. | 83226-2001 | 83226-2001-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83226-2001-1) / 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 |
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