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Details for New Drug Application (NDA): 206255
NDA 206255 describes SOOLANTRA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. There are twelve 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. Eight suppliers are listed 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. Eight suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 206255
| Tradename: | SOOLANTRA |
| Applicant: | Galderma Labs Lp |
| Ingredient: | ivermectin |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206255
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255 | NDA | Galderma Laboratories, L.P. | 0299-3823 | 0299-3823-02 | 1 TUBE in 1 BLISTER PACK (0299-3823-02) > 2 g in 1 TUBE |
| SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255 | NDA | Galderma Laboratories, L.P. | 0299-3823 | 0299-3823-30 | 1 TUBE in 1 CARTON (0299-3823-30) > 30 g in 1 TUBE |
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? | |||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 26, 2019 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
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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