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Athena Athena

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Approved Drug Products containing Gemcitabine listed in the FDA Orange Book. Original Data : FDA Website

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01 ACCORD HLTHCARE (7)

02 ACTAVIS INC (3)

03 ACTAVIS TOTOWA (3)

04 AM REGENT (2)

05 APOTEX (3)

06 DR REDDYS LABS LTD (3)

07 EMCURE PHARMS LTD (2)

08 EUROHLTH INTL (1)

09 FRESENIUS KABI USA (6)

10 GLAND PHARMA LTD (2)

11 HAMELN RDS GMBH (2)

12 HIKMA (3)

13 HIKMA INTL PHARMS (2)

14 HOSPIRA (2)

15 HOSPIRA INC (4)

16 JIANGSU HANSOH PHARM (2)

17 LILLY (2)

18 MEITHEAL (3)

19 MYLAN LABS LTD (6)

20 NOVAST LABS (3)

21 SAGENT PHARMS (2)

22 SAGENT PHARMS INC (3)

23 SHILPA (5)

24 SUN PHARM (12)

25 TEVA PARENTERAL (1)

26 TEVA PHARMS (2)

27 TEYRO LABS (2)

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01 INJECTABLE; INJECTION (4)

02 INJECTABLE;INJECTION (70)

03 SOLUTION;INTRAVENOUS (14)

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01 DISCN (34)

02 RX (50)

03 Blank (4)

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01 GEMCITABINE (2)

02 GEMCITABINE HYDROCHLORIDE (74)

03 GEMZAR (2)

04 INFUGEM (10)

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01 No (65)

02 Yes (19)

03 Blank (4)

URL Supplier Web Content
INJECTABLE;INJECTION
EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-05-15
20509
GEMZAR
DISCN
Yes
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INJECTABLE;INJECTION
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-05-15
20509
GEMZAR
DISCN
Yes
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INJECTABLE; INJECTION
200MG
78460
GEMCITABINE
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INJECTABLE;INJECTION
EQ 200MG BASE/VIAL
2011-07-25
78339
GEMCITABINE HYDROCHLOR...
RX
No
AP
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INJECTABLE;INJECTION
EQ 1GM BASE/VIAL
2011-07-25
78339
GEMCITABINE HYDROCHLOR...
RX
No
AP
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INJECTABLE;INJECTION
EQ 200MG BASE/VIAL
2011-07-25
78433
GEMCITABINE HYDROCHLOR...
RX
No
AP
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INJECTABLE;INJECTION
EQ 1GM BASE/VIAL
2011-07-25
78433
GEMCITABINE HYDROCHLOR...
RX
No
AP
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INJECTABLE;INJECTION
EQ 1GM BASE/VIAL
2011-01-25
77983
GEMCITABINE HYDROCHLOR...
DISCN
No
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INJECTABLE;INJECTION
EQ 200MG BASE/VIAL
2011-01-25
77983
GEMCITABINE HYDROCHLOR...
DISCN
No
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INJECTABLE;INJECTION
EQ 200MG BASE/VIAL
2011-07-25
78759
GEMCITABINE HYDROCHLOR...
RX
No
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