Product Details for ANDA 090799
GEMCITABINE HYDROCHLORIDE (GEMCITABINE HYDROCHLORIDE)
EQ 200MG BASE/VIAL
Marketing Status: Prescription
EQ 1GM BASE/VIAL
Marketing Status: Prescription
EQ 2GM BASE/VIAL
Marketing Status: Prescription
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: A090799
Product Number: 001
Approval Date: Jul 25, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
GEMCITABINE HYDROCHLORIDE (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: A090799
Product Number: 001
Approval Date: Jul 25, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A090799
Product Number: 002
Approval Date: Jul 25, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
GEMCITABINE HYDROCHLORIDE (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: A090799
Product Number: 002
Approval Date: Jul 25, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 2GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: GEMCITABINE HYDROCHLORIDE
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090799
Product Number: 003
Approval Date: May 16, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090799
Product Number: 003
Approval Date: May 16, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status: Prescription
Patent and Exclusivity Information