Details for New Drug Application (NDA): 206255
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The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Fourteen 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 | 0299-3823-00 | 2 g in 1 TUBE (0299-3823-00) |
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 |
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: | See Plans and Pricing | Patent Expiration: | Mar 13, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA. | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Apr 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | 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 | See Plans and Pricing | See Plans and Pricing |
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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