Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078433

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GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
EQ 200MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 200MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078433
Product Number: 001
Approval Date: Jul 25, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078433
Product Number: 002
Approval Date: Jul 25, 2011
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information