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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016801

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XYLOCAINE PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016801
Product Number: 005
Approval Date: Jan 19, 1988
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
XYLOCAINE PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016801
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 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4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016801
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
XYLOCAINE PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
10% **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 PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016801
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
XYLOCAINE PRESERVATIVE FREE (LIDOCAINE HYDROCHLORIDE)
20% **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 PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20% **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: N016801
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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