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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208313

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INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 001
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 002
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 003
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 004
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 005
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 006
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 007
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 008
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 009
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
INFUGEM (GEMCITABINE HYDROCHLORIDE)
EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: INFUGEM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208313
Product Number: 010
Approval Date: Jul 16, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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