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

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01 ALLERGAN (1)

02 RANBAXY LABS LTD (3)

03 ALTAIRE PHARMS INC (1)

04 ALVOGEN (2)

05 AMNEAL (2)

06 APOTEX INC (2)

07 BAUSCH AND LOMB (2)

08 BEDFORD (1)

09 CADILA PHARMS LTD (3)

10 CAPLIN (1)

11 DAIICHI (1)

12 DR REDDYS LABS LTD (3)

13 EPIC PHARMA LLC (1)

14 FDC LTD (2)

15 HIKMA (1)

16 JANSSEN PHARMS (3)

17 LARKEN LABS (3)

18 MANKIND PHARMA (2)

19 ORTHO MCNEIL PHARM (5)

20 SANDOZ (3)

21 SENTISS (1)

22 TEVA (3)

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01 INJECTABLE;INJECTION (6)

02 SOLUTION/DROPS;OPHTHALMIC (12)

03 SOLUTION/DROPS;OTIC (10)

04 TABLET;ORAL (18)

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01 DISCN (22)

02 RX (24)

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01 FLOXIN (5)

02 FLOXIN IN DEXTROSE 5% (1)

03 FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER (2)

04 FLOXIN OTIC (1)

05 OCUFLOX (1)

06 OFLOXACIN (36)

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01 No (41)

02 Yes (5)

URL Supplier Web Content
SOLUTION/DROPS;OPHTHALMIC
0.3%
1993-07-30
19921
OCUFLOX
RX
Yes
AT
Abbvie CB

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
200MG
2003-09-02
76220
OFLOXACIN
DISCN
No
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TABLET;ORAL
300MG
2003-09-02
76220
OFLOXACIN
DISCN
No
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TABLET;ORAL
400MG
2003-09-02
76220
OFLOXACIN
DISCN
No
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TABLET;ORAL
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1990-12-28
19735
FLOXIN
DISCN
Yes
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TABLET;ORAL
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1990-12-28
19735
FLOXIN
DISCN
Yes
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TABLET;ORAL
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1990-12-28
19735
FLOXIN
DISCN
Yes
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INJECTABLE;INJECTION
400MG/100ML
1992-03-31
20087
FLOXIN IN DEXTROSE 5%
DISCN
No
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INJECTABLE;INJECTION
20MG/ML
1992-03-31
20087
FLOXIN
DISCN
No
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INJECTABLE;INJECTION
40MG/ML
1992-03-31
20087
FLOXIN
DISCN
No
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