Details for New Drug Application (NDA): 017584
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The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 017584
Tradename: | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017584
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 017584
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 017584 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1364 | 51662-1364-1 | 5 mL in 1 VIAL, SINGLE-DOSE (51662-1364-1) |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 017584 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1364 | 51662-1364-3 | 25 POUCH in 1 CASE (51662-1364-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1364-2) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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