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Approved Drug Products containing 8809 listed in the FDA Orange Book. Original Data : FDA Website

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01 HOSPIRA (3)

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01 INJECTABLE;INJECTION (3)

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01 DISCN (3)

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01 M.V.I.-12 ADULT (3)

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01 No (2)

02 Yes (1)

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INJECTABLE; INJECT...
20MG/ML;0.006MG/ML...
2004-04-22
8809
M.V.I.-12 ADULT
DISCN
No
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URL Supplier Web Content
INJECTABLE; INJECT...
20MG/ML;0.006MG/ML...
2004-09-09
8809
M.V.I.-12 ADULT
DISCN
Yes
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INJECTABLE; INJECT...
10MG/ML;0.006MG/ML...
1985-08-08
8809
M.V.I.-12 ADULT
DISCN
No
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Looking for FDA Orange Book APPLICATION 8809

Looking for FDA Orange Book APPLICATION 8809 3

19

Hospira, Inc., based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E, with a corresponding application number 8809.

Regulatory Information DISCN

With a dosage strength 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2004-04-22

18

Hospira, Inc., based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E, with a corresponding application number 8809.

Regulatory Information DISCN

With a dosage strength 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 2004-09-09

17

Hospira, Inc., based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E, with a corresponding application number 8809.

Regulatory Information DISCN

With a dosage strength 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1985-08-08

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