Details for New Drug Application (NDA): 089408
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NDA 089408 describes POLOCAINE-MPF, which is a drug marketed by Fresenius Kabi Usa and is included in three NDAs. It is available from two suppliers. Additional details are available on the POLOCAINE-MPF profile page.
The generic ingredient in POLOCAINE-MPF is mepivacaine hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mepivacaine hydrochloride profile page.
The generic ingredient in POLOCAINE-MPF is mepivacaine hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mepivacaine hydrochloride profile page.
Summary for 089408
| Tradename: | POLOCAINE-MPF |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | mepivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 089408
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 089408
Suppliers and Packaging for NDA: 089408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLOCAINE-MPF | mepivacaine hydrochloride | INJECTABLE;INJECTION | 089408 | ANDA | Fresenius Kabi USA, LLC | 63323-293 | 63323-293-37 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-293-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-293-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.5% | ||||
| Approval Date: | Dec 1, 1986 | TE: | AP | RLD: | No | ||||
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