Details for New Drug Application (NDA): 021717
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The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.
Summary for 021717
Tradename: | PLIAGLIS |
Applicant: | Crescita Therap |
Ingredient: | lidocaine; tetracaine |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021717
Generic Entry Date for 021717*:
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: 021717
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 021717
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717 | NDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-5305 | 51672-5305-2 | 1 TUBE in 1 CARTON (51672-5305-2) / 30 g in 1 TUBE |
PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717 | NDA AUTHORIZED GENERIC | Innovida Pharmaceutique Corporation | 71800-631 | 71800-631-04 | 4 TUBE in 1 CARTON (71800-631-04) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 7%;7% | ||||
Approval Date: | Jun 29, 2006 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 14, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 14, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 14, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021717
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Crescita Therap | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Crescita Therap | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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