Details for New Drug Application (NDA): 018461
✉ Email this page to a colleague
NDA 018461 describes LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs. It is available from three suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 018461
| Tradename: | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 018461
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 018461
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER | lidocaine hydrochloride | INJECTABLE;INJECTION | 018461 | NDA | Baxter Healthcare Corporation | 0338-0409 | 0338-0409-02 | 24 BAG in 1 CARTON (0338-0409-02) / 250 mL in 1 BAG |
| LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER | lidocaine hydrochloride | INJECTABLE;INJECTION | 018461 | NDA | Baxter Healthcare Corporation | 0338-0409 | 0338-0409-03 | 18 BAG in 1 CARTON (0338-0409-03) / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 400MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
