Details for New Drug Application (NDA): 213923
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NDA 213923 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 213923
| Tradename: | LIDOCAINE AND PRILOCAINE |
| Applicant: | Alembic |
| Ingredient: | lidocaine; prilocaine |
| Patents: | 0 |
Pharmacology for NDA: 213923
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 213923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213923 | ANDA | Alembic Pharmaceuticals Inc. | 62332-582 | 62332-582-04 | 1 TUBE in 1 CARTON (62332-582-04) / 5 g in 1 TUBE |
| LIDOCAINE AND PRILOCAINE | lidocaine; prilocaine | CREAM;TOPICAL | 213923 | ANDA | Alembic Pharmaceuticals Inc. | 62332-582 | 62332-582-31 | 1 TUBE in 1 CARTON (62332-582-31) / 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: | Apr 8, 2022 | TE: | AB | RLD: | No | ||||
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