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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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PharmaCompass

01

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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Dosage Strength : EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :

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02

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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Dosage Strength : EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 :

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03

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE

Brand Name : GEMCITABINE

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 200MG

Approval Date :

Application Number : 78460

RX/OTC/DISCN :

RLD :

TE Code :

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04

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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

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05

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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

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06

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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

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07

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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

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08

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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 :

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09

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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 :

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10

PREP
Not Confirmed
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PREP
Not Confirmed

GEMCITABINE HYDROCHLORIDE

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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