Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 010417

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XYLOCAINE 4% PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
4%
Marketing Status: Discontinued

Active Ingredient: LIDOCAINE HYDROCHLORIDE
Proprietary Name: XYLOCAINE 4% PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N010417
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

XYLOCAINE 4% PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: LIDOCAINE HYDROCHLORIDE
Proprietary Name: XYLOCAINE 4% PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N010417
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information