Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213175

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GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
200MG/5.26ML (38MG/ML)
Marketing Status: Prescription

Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/5.26ML (38MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213175
Product Number: 001
Approval Date: Mar 7, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
1GM/26.3ML (38MG/ML)
Marketing Status: Prescription

Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/26.3ML (38MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213175
Product Number: 002
Approval Date: Mar 7, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
2GM/52.6ML (38MG/ML)
Marketing Status: Prescription

Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/52.6ML (38MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A213175
Product Number: 003
Approval Date: Mar 7, 2023
Applicant Holder Full Name: HIKMA PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information