Details for New Drug Application (NDA): 021201
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NDA 021201 describes ASCLERA, which is a drug marketed by Chemisch Fbrk Krsslr and is included in one NDA. It is available from one supplier. Additional details are available on the ASCLERA profile page.
The generic ingredient in ASCLERA is polidocanol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.
The generic ingredient in ASCLERA is polidocanol. There is one drug master file entry for this compound. 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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