Details for New Drug Application (NDA): 009435
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The generic ingredient in NESACAINE-MPF is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
Summary for 009435
| Tradename: | NESACAINE-MPF |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | chloroprocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 009435
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 009435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NESACAINE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435 | NDA | Henry Schein, Inc. | 0404-9927 | 0404-9927-30 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9927-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| NESACAINE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1401 | 51662-1401-1 | 30 mL in 1 VIAL, MULTI-DOSE (51662-1401-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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