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01 7ACCORD HLTHCARE
02 3ACTAVIS INC
03 3ACTAVIS TOTOWA
04 2AM REGENT
05 3APOTEX
06 3AVYXA HOLDINGS
07 3DR REDDYS LABS LTD
08 2EMCURE PHARMS LTD
09 1EUROHLTH INTL
10 6FRESENIUS KABI USA
11 2GLAND
12 2HAMELN RDS GMBH
13 3HIKMA
14 2HIKMA INTL PHARMS
15 2HOSPIRA
16 4HOSPIRA INC
17 1JANSSEN BIOTECH
18 2JIANGSU HANSOH PHARM
19 2LILLY
20 3MEITHEAL
21 3MYLAN LABS LTD
22 3NOVAST LABS
23 3PHARMOBEDIENT
24 2SAGENT PHARMS
25 3SAGENT PHARMS INC
26 5SHILPA
27 12SUN PHARM
28 1TEVA PARENTERAL
29 2TEVA PHARMS
30 2TEYRO LABS
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01 4INJECTABLE; INJECTION
02 70INJECTABLE;INJECTION
03 17SOLUTION;INTRAVENOUS
04 1SOLUTION;TOPICAL
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01 40DISCN
02 47RX
03 5Blank
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01 3AVGEMSI
02 2GEMCITABINE
03 74GEMCITABINE HYDROCHLORIDE
04 2GEMZAR
05 10INFUGEM
06 1INLEXZO
01 65No
02 22Yes
03 5Blank
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Dosage Strength : EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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