Details for New Drug Application (NDA): 207962
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NDA 207962 describes ZTLIDO, which is a drug marketed by Scilex Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZTLIDO profile page.
The generic ingredient in ZTLIDO is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lidocaine profile page.
The generic ingredient in ZTLIDO is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lidocaine profile page.
Summary for 207962
| Tradename: | ZTLIDO |
| Applicant: | Scilex Pharms |
| Ingredient: | lidocaine |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207962
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 207962
Suppliers and Packaging for NDA: 207962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZTLIDO | lidocaine | PATCH;TOPICAL | 207962 | NDA | Scilex Pharmaceuticals Inc. | 69557-111 | 69557-111-03 | 3 POUCH in 1 CARTON (69557-111-03) / 1 PATCH in 1 POUCH |
| ZTLIDO | lidocaine | PATCH;TOPICAL | 207962 | NDA | Scilex Pharmaceuticals Inc. | 69557-111 | 69557-111-30 | 30 POUCH in 1 CARTON (69557-111-30) / 1 PATCH in 1 POUCH (69557-111-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PATCH;TOPICAL | Strength | 1.8% | ||||
| Approval Date: | Feb 28, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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