Details for New Drug Application (NDA): 088586
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NDA 088586 describes LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Kabi Usa and Hospira and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 088586
| Tradename: | LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 088586
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 088586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088586 | ANDA | Fresenius Kabi USA, LLC | 63323-201 | 63323-201-10 | 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03) |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | lidocaine hydrochloride | INJECTABLE;INJECTION | 088586 | ANDA | Fresenius Kabi USA, LLC | 63323-201 | 63323-201-10 | 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
| Approval Date: | Jul 24, 1985 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
| 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 | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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