Details for New Drug Application (NDA): 213036
✉ Email this page to a colleague
NDA 213036 describes ARTESUNATE, which is a drug marketed by Amivas and is included in one NDA. It is available from one supplier. Additional details are available on the ARTESUNATE profile page.
The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artesunate profile page.
The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artesunate profile page.
Summary for 213036
| Tradename: | ARTESUNATE |
| Applicant: | Amivas |
| Ingredient: | artesunate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213036
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARTESUNATE | artesunate | POWDER;INTRAVENOUS | 213036 | NDA | Amivas, Inc | 73607-011 | 73607-011-11 | 2 KIT in 1 CARTON (73607-011-11) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (73607-002-01) * 1 SOLUTION in 1 VIAL (73607-003-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 110MG/VIAL | ||||
| Approval Date: | May 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE INITIAL TREATMENT OF SEVERE MALARIA IN ADULT AND PEDIATRIC PATIENTS TO ALWAYS BE FOLLOWED BY A COMPLETE TREATMENT COURSE OF AN APPROPRIATE ORAL ANTIMALARIAL REGIMEN | ||||||||
| Regulatory Exclusivity Expiration: | May 26, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Complete Access Available with Subscription
