Details for New Drug Application (NDA): 212482
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NDA 212482 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, and Rhodes Pharms, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the LIDOCAINE AND PRILOCAINE profile page.
The generic ingredient in LIDOCAINE AND PRILOCAINE 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.
The generic ingredient in LIDOCAINE AND PRILOCAINE 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 212482
| Tradename: | LIDOCAINE AND PRILOCAINE |
| Applicant: | Padagis Us |
| Ingredient: | lidocaine; prilocaine |
| Patents: | 0 |
Pharmacology for NDA: 212482
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 212482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 212482 | ANDA | Padagis US LLC | 0574-2042 | 0574-2042-30 | 1 TUBE in 1 CARTON (0574-2042-30) / 30 g in 1 TUBE |
| LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 212482 | ANDA | A-S Medication Solutions | 50090-6589 | 50090-6589-0 | 1 TUBE in 1 CARTON (50090-6589-0) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5%;2.5% | ||||
| Approval Date: | Jul 27, 2021 | TE: | AB | RLD: | No | ||||
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