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. It is available from three suppliers. There are five 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. Twenty-three 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. Twenty-three 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: | 5 |
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: | 10,206,939 | Patent Expiration: | Mar 13, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA | ||||||||
| Patent: | 9,089,587 | Patent Expiration: | Mar 13, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA | ||||||||
| Patent: | 9,233,117 | Patent Expiration: | Mar 13, 2034 | Product Flag? | 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 | 11,033,565 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,093,219 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,815,816 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,470,788 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 5,952,372 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,080,530 | ⤷ Try for Free |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 7,550,440 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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