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Approved Drug Products containing 90343 listed in the FDA Orange Book. Original Data : FDA Website

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01 INFORLIFE (3)

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01 INJECTABLE;INJECTION (3)

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01 RX (3)

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01 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER (3)

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01 No (3)

URL Supplier Web Content
INJECTABLE; INJECT...
EQ 750MG/150ML (EQ...
2011-07-07
90343
LEVOFLOXACIN IN DE...
RX
No
AP
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URL Supplier Web Content
INJECTABLE; INJECT...
EQ 250MG/50ML (EQ ...
2011-07-07
90343
LEVOFLOXACIN IN DE...
RX
No
AP
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
INJECTABLE; INJECT...
EQ 500MG/100ML (EQ...
2011-07-07
90343
LEVOFLOXACIN IN DE...
RX
No
AP
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 90343

Looking for FDA Orange Book APPLICATION 90343 3

19

ACS DOBFAR SPA, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVOFLOXACIN, with a corresponding application number 90343.

Regulatory Information RX

With a dosage strength EQ 750MG/150ML (EQ 5MG/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2011-07-07

Therapeutic Equivalence (TE) Code AP

18

ACS DOBFAR SPA, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVOFLOXACIN, with a corresponding application number 90343.

Regulatory Information RX

With a dosage strength EQ 250MG/50ML (EQ 5MG/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2011-07-07

Therapeutic Equivalence (TE) Code AP

17

ACS DOBFAR SPA, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is LEVOFLOXACIN, with a corresponding application number 90343.

Regulatory Information RX

With a dosage strength EQ 500MG/100ML (EQ 5MG/ML)

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2011-07-07

Therapeutic Equivalence (TE) Code AP

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