Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203704

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CEFEPIME HYDROCHLORIDE (CEFEPIME HYDROCHLORIDE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFEPIME HYDROCHLORIDE
Proprietary Name: CEFEPIME HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A203704
Product Number: 001
Approval Date: Feb 1, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFEPIME HYDROCHLORIDE (CEFEPIME HYDROCHLORIDE)
EQ 1GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFEPIME HYDROCHLORIDE
Proprietary Name: CEFEPIME HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A203704
Product Number: 002
Approval Date: Feb 1, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFEPIME HYDROCHLORIDE (CEFEPIME HYDROCHLORIDE)
EQ 2GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFEPIME HYDROCHLORIDE
Proprietary Name: CEFEPIME HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A203704
Product Number: 003
Approval Date: Feb 1, 2016
Applicant Holder Full Name: QILU PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information