Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016812

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KETALAR (KETAMINE HYDROCHLORIDE)
EQ 10MG BASE/ML
Marketing Status: Prescription

Active Ingredient: KETAMINE HYDROCHLORIDE
Proprietary Name: KETALAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016812
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

KETALAR (KETAMINE HYDROCHLORIDE)
EQ 50MG BASE/ML
Marketing Status: Prescription

Active Ingredient: KETAMINE HYDROCHLORIDE
Proprietary Name: KETALAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016812
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

KETALAR (KETAMINE HYDROCHLORIDE)
EQ 100MG BASE/ML
Marketing Status: Prescription

Active Ingredient: KETAMINE HYDROCHLORIDE
Proprietary Name: KETALAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016812
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information