Details for New Drug Application (NDA): 204153
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The generic ingredient in LUZU is luliconazole. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the luliconazole profile page.
Summary for 204153
Tradename: | LUZU |
Applicant: | Bausch |
Ingredient: | luliconazole |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204153
Generic Entry Date for 204153*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 204153
Mechanism of Action | Cytochrome P450 2C19 Inhibitors |
Suppliers and Packaging for NDA: 204153
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LUZU | luliconazole | CREAM;TOPICAL | 204153 | NDA | Oceanside Pharmaceuticals | 68682-850 | 68682-850-60 | 1 TUBE in 1 CARTON (68682-850-60) / 60 g in 1 TUBE |
LUZU | luliconazole | CREAM;TOPICAL | 204153 | NDA | Bausch Health US, LLC | 99207-850 | 99207-850-02 | 12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Nov 14, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 28, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 6, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF FUNGAL INFECTIONS | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 6, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 204153
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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