Details for New Drug Application (NDA): 210867
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NDA 210867 describes MOXIDECTIN, which is a drug marketed by Mdgh and is included in one NDA. It is available from one supplier. Additional details are available on the MOXIDECTIN profile page.
The generic ingredient in MOXIDECTIN is moxidectin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the moxidectin profile page.
The generic ingredient in MOXIDECTIN is moxidectin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the moxidectin profile page.
Summary for 210867
| Tradename: | MOXIDECTIN |
| Applicant: | Mdgh |
| Ingredient: | moxidectin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210867
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOXIDECTIN | moxidectin | TABLET;ORAL | 210867 | NDA | Medicines Development for Global Health | 71705-050 | 71705-050-01 | 500 TABLET in 1 BOTTLE, PLASTIC (71705-050-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jun 13, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 13, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PATIENTS AGED 12 YEARS AND OLDER | ||||||||
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