Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065169

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CEFTRIAXONE (CEFTRIAXONE SODIUM)
EQ 250MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFTRIAXONE SODIUM
Proprietary Name: CEFTRIAXONE
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 250MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065169
Product Number: 001
Approval Date: May 9, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFTRIAXONE (CEFTRIAXONE SODIUM)
EQ 500MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFTRIAXONE SODIUM
Proprietary Name: CEFTRIAXONE
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065169
Product Number: 002
Approval Date: May 9, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFTRIAXONE (CEFTRIAXONE SODIUM)
EQ 1GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFTRIAXONE SODIUM
Proprietary Name: CEFTRIAXONE
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065169
Product Number: 003
Approval Date: May 9, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFTRIAXONE (CEFTRIAXONE SODIUM)
EQ 2GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFTRIAXONE SODIUM
Proprietary Name: CEFTRIAXONE
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065169
Product Number: 004
Approval Date: May 9, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information