Details for New Drug Application (NDA): 215922
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NDA 215922 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, Edenbridge Pharms, Rubicon, and Senores Pharms, and is included in eight NDAs. It is available from eighteen suppliers. Additional details are available on the IVERMECTIN profile page.
The generic ingredient in IVERMECTIN is ivermectin. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
The generic ingredient in IVERMECTIN is ivermectin. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 215922
| Tradename: | IVERMECTIN |
| Applicant: | Rubicon |
| Ingredient: | ivermectin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215922
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IVERMECTIN | ivermectin | TABLET;ORAL | 215922 | ANDA | Advagen Pharma Ltd | 72888-206 | 72888-206-09 | 10 BLISTER PACK in 1 CARTON (72888-206-09) / 10 TABLET in 1 BLISTER PACK (72888-206-08) |
| IVERMECTIN | ivermectin | TABLET;ORAL | 215922 | ANDA | Advagen Pharma Ltd | 72888-206 | 72888-206-30 | 30 TABLET in 1 BOTTLE (72888-206-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Jan 22, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Jan 22, 2025 | TE: | RLD: | No | |||||
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