Details for New Drug Application (NDA): 088586
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The generic ingredient in LIDOCAINE HYDROCHLORIDE 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 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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