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Details for New Drug Application (NDA): 206255
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NDA 206255 describes SOOLANTRA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SOOLANTRA profile page.
The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Additional details are available on the ivermectin profile page.
The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Additional details are available on the ivermectin profile page.
Summary for 206255
| Tradename: | SOOLANTRA |
| Applicant: | Galderma Labs Lp |
| Ingredient: | ivermectin |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 206255
Paragraph IV (Patent) Challenges for 206255
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SOOLANTRA | CREAM;TOPICAL | ivermectin | 206255 | 2016-12-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Dec 19, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Mar 13, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | Start Trial | Patent Expiration: | Apr 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Apr 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 206255
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | Start Trial | Start Trial |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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