Details for New Drug Application (NDA): 218411
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The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 218411
| Tradename: | LIDOCAINE HYDROCHLORIDE |
| Applicant: | The J Molner |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218411
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 218411
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;TOPICAL | 218411 | ANDA | The J. Molner Company LLC | 83148-043 | 83148-043-50 | 1 BOTTLE in 1 CARTON (83148-043-50) / 50 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 4% | ||||
| Approval Date: | Apr 29, 2024 | TE: | AT | RLD: | No | ||||
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