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Approved Drug Products containing 19437 listed in the FDA Orange Book. Original Data : FDA Website

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01 ICU MEDICAL INC (5)

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01 INJECTABLE;INJECTION (5)

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01 DISCN (5)

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01 AMINOSYN II 10% W/ ELECTROLYTES (1)

02 AMINOSYN II 3.5% M (1)

03 AMINOSYN II 7% W/ ELECTROLYTES (1)

04 AMINOSYN II 8.5% W/ ELECTROLYTES (1)

05 AMINOSYN II 8.5% W/ELECTROLYTES (1)

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01 No (5)

URL Supplier Web Content
INJECTABLE; INJECT...
3.5%;30MG/100ML;97...
1986-04-03
19437
AMINOSYN II 3.5% M
DISCN
No
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INJECTABLE; INJECT...
8.5%;102MG/100ML;4...
1986-04-03
19437
AMINOSYN II 8.5% W...
DISCN
No
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INJECTABLE; INJECT...
8.5%;102MG/100ML;4...
2002-10-25
19437
AMINOSYN II 8.5% W...
DISCN
No
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INJECTABLE; INJECT...
7%;102MG/100ML;45M...
1986-04-03
19437
AMINOSYN II 7% W/ ...
DISCN
No
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INJECTABLE; INJECT...
10%;102MG/100ML;45...
1986-04-03
19437
AMINOSYN II 10% W/...
DISCN
No
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Looking for FDA Orange Book APPLICATION 19437

Looking for FDA Orange Book APPLICATION 19437 5

19

ICU Medical, based in U.S.A, is a pharmaceutical company.

One of their notable products is AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, with a corresponding application number 19437.

Regulatory Information DISCN

With a dosage strength 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1986-04-03

18

ICU Medical, based in U.S.A, is a pharmaceutical company.

One of their notable products is AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE, with a corresponding application number 19437.

Regulatory Information DISCN

With a dosage strength 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1986-04-03

17

ICU Medical, based in U.S.A, is a pharmaceutical company.

One of their notable products is AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, with a corresponding application number 19437.

Regulatory Information DISCN

With a dosage strength 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 2002-10-25

16

ICU Medical, based in U.S.A, is a pharmaceutical company.

One of their notable products is AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE, with a corresponding application number 19437.

Regulatory Information DISCN

With a dosage strength 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1986-04-03

15

ICU Medical, based in U.S.A, is a pharmaceutical company.

One of their notable products is AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE, with a corresponding application number 19437.

Regulatory Information DISCN

With a dosage strength 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug No

Approved since 1986-04-03

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