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Last Updated: November 21, 2024

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-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 088586
Pharmacology for NDA: 088586
Physiological EffectLocal 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:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Jul 24, 1985TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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