Details for New Drug Application (NDA): 021201
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The generic ingredient in ASCLERA is polidocanol. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.
Summary for 021201
Tradename: | ASCLERA |
Applicant: | Chemisch Fbrk Krsslr |
Ingredient: | polidocanol |
Patents: | 0 |
Pharmacology for NDA: 021201
Mechanism of Action | Sclerosing Activity |
Physiological Effect | Vascular Sclerosing Activity |
Suppliers and Packaging for NDA: 021201
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASCLERA | polidocanol | SOLUTION;INTRAVENOUS | 021201 | NDA | Methapharm, Inc | 67850-140 | 67850-140-05 | 2 mL in 1 AMPULE (67850-140-05) |
ASCLERA | polidocanol | SOLUTION;INTRAVENOUS | 021201 | NDA | Methapharm, Inc | 67850-141 | 67850-141-05 | 2 mL in 1 AMPULE (67850-141-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/2ML (5MG/ML) | ||||
Approval Date: | Mar 30, 2010 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/2ML (10MG/ML) | ||||
Approval Date: | Mar 30, 2010 | TE: | RLD: | Yes |
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