Details for New Drug Application (NDA): 021451
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The generic ingredient in ORAQIX is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
Summary for 021451
Tradename: | ORAQIX |
Applicant: | Dentsply Pharm |
Ingredient: | lidocaine; prilocaine |
Patents: | 0 |
Pharmacology for NDA: 021451
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 021451
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451 | NDA | Dentsply Pharmaceutical | 66312-110 | 66312-110-20 | 20 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;PERIODONTAL | Strength | 2.5%;2.5% | ||||
Approval Date: | Dec 19, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 021451
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Dentsply Pharm | ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451-001 | Dec 19, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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