Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078433
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091594 ACCORD HLTHCARE
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079160 ACTAVIS TOTOWA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078759 CIPLA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091365 DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202063 EMCURE PHARMS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090799 FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204520 GLAND PHARMA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078339 HOSPIRA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202485 JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200145 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207575 SHILPA MEDICARE LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078433 SUN PHARMA GLOBAL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 077983 TEVA PHARMS
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020509 LILLY

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091594 ACCORD HLTHCARE
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079160 ACTAVIS TOTOWA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078759 CIPLA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091365 DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202063 EMCURE PHARMS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090799 FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204520 GLAND PHARMA LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078339 HOSPIRA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202485 JIANGSU HANSOH PHARM
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200145 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207575 SHILPA MEDICARE LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078433 SUN PHARMA GLOBAL
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 077983 TEVA PHARMS
GEMZAR GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020509 LILLY

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