Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050817

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CEFEPIME IN PLASTIC CONTAINER (CEFEPIME HYDROCHLORIDE)
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: CEFEPIME HYDROCHLORIDE
Proprietary Name: CEFEPIME IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050817
Product Number: 001
Approval Date: Aug 5, 2008
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFEPIME IN PLASTIC CONTAINER (CEFEPIME HYDROCHLORIDE)
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: CEFEPIME HYDROCHLORIDE
Proprietary Name: CEFEPIME IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050817
Product Number: 002
Approval Date: Aug 5, 2008
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information