Details for New Drug Application (NDA): 089407
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NDA 089407 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 089407
| Tradename: | POLOCAINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | mepivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 089407
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 089407
Suppliers and Packaging for NDA: 089407
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLOCAINE | mepivacaine hydrochloride | INJECTABLE;INJECTION | 089407 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1534 | 51662-1534-3 | 25 POUCH in 1 BOX (51662-1534-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1534-2) / 50 mL in 1 VIAL, MULTI-DOSE |
| POLOCAINE | mepivacaine hydrochloride | INJECTABLE;INJECTION | 089407 | ANDA | Fresenius Kabi USA, LLC | 63323-283 | 63323-283-57 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
| Approval Date: | Dec 1, 1986 | TE: | AP | RLD: | No | ||||
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