01 7ACCORD HLTHCARE
02 3ACTAVIS INC
03 3ACTAVIS TOTOWA
04 2AM REGENT
05 3APOTEX
06 3DR REDDYS LABS LTD
07 2EMCURE PHARMS LTD
08 1EUROHLTH INTL
09 6FRESENIUS KABI USA
10 2GLAND PHARMA LTD
11 2HAMELN RDS GMBH
12 3HIKMA
13 2HIKMA INTL PHARMS
14 2HOSPIRA
15 4HOSPIRA INC
16 2JIANGSU HANSOH PHARM
17 2LILLY
18 3MEITHEAL
19 3MYLAN LABS LTD
20 3NORVIUM BIOSCIENCE
21 3NOVAST LABS
22 2SAGENT PHARMS
23 3SAGENT PHARMS INC
24 5SHILPA
25 12SUN PHARM
26 1TEVA PARENTERAL
27 2TEVA PHARMS
28 2TEYRO LABS
01 4INJECTABLE; INJECTION
02 70INJECTABLE;INJECTION
03 14SOLUTION;INTRAVENOUS
01 37DISCN
02 47RX
03 4Blank
01 2GEMCITABINE
02 74GEMCITABINE HYDROCHLORIDE
03 2GEMZAR
04 10INFUGEM
01 65No
02 19Yes
03 4Blank
RLD : Yes
TE Code :
Brand Name : GEMZAR
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1996-05-15
Application Number : 20509
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : GEMZAR
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1996-05-15
Application Number : 20509
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : GEMCITABINE
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 200MG
Approval Date :
Application Number : 78460
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AP
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MG BASE/VIAL
Approval Date : 2011-07-25
Application Number : 78339
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2011-07-25
Application Number : 78339
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MG BASE/VIAL
Approval Date : 2011-07-25
Application Number : 78433
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2011-07-25
Application Number : 78433
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2011-01-25
Application Number : 77983
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MG BASE/VIAL
Approval Date : 2011-01-25
Application Number : 77983
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MG BASE/VIAL
Approval Date : 2011-07-25
Application Number : 78759
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
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