Details for New Drug Application (NDA): 089410
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NDA 089410 describes POLOCAINE, which is a drug marketed by Dentsply Pharm and Fresenius Kabi Usa and is included in seven NDAs. It is available from three suppliers. Additional details are available on the POLOCAINE profile page.
The generic ingredient in POLOCAINE is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.
The generic ingredient in POLOCAINE is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.
Summary for 089410
| Tradename: | POLOCAINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | mepivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 089410
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 089410
Suppliers and Packaging for NDA: 089410
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLOCAINE | mepivacaine hydrochloride | INJECTABLE;INJECTION | 089410 | ANDA | A-S Medication Solutions | 50090-4408 | 50090-4408-0 | 1 VIAL, MULTI-DOSE in 1 BAG (50090-4408-0) / 50 mL in 1 VIAL, MULTI-DOSE |
| POLOCAINE | mepivacaine hydrochloride | INJECTABLE;INJECTION | 089410 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1535 | 51662-1535-3 | 21 POUCH in 1 BOX (51662-1535-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1535-2) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
| Approval Date: | Dec 1, 1986 | TE: | AP | RLD: | No | ||||
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