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Approved Drug Products containing 208418 listed in the FDA Orange Book. Original Data : FDA Website

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01 5FRESENIUS KABI USA

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01

Brand Name : CALCIUM GLUCONATE

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Brand Name : CALCIUM GLUCONATE

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Fresenius Kabi USA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE

Dosage Strength : 10GM/100ML (100MG/ML)

Approval Date : 2017-06-15

Application Number : 208418

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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02

Brand Name : CALCIUM GLUCONATE

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Not Confirmed
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Brand Name : CALCIUM GLUCONATE

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Not Confirmed
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Fresenius Kabi USA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE

Dosage Strength : 1GM/10ML (100MG/ML)

Approval Date : 2017-06-15

Application Number : 208418

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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03

Brand Name : CALCIUM GLUCONATE IN...

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Brand Name : CALCIUM GLUCONATE IN...

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Not Confirmed
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Fresenius Kabi USA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE IN SOD...

Dosage Strength : 1GM/50ML (20MG/ML)

Approval Date : 2021-06-17

Application Number : 208418

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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04

Brand Name : CALCIUM GLUCONATE

Luxepack
Not Confirmed
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Brand Name : CALCIUM GLUCONATE

Luxepack
Not Confirmed
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Fresenius Kabi USA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE

Dosage Strength : 5GM/50ML (100MG/ML)

Approval Date : 2017-06-15

Application Number : 208418

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

Brand Name : CALCIUM GLUCONATE IN...

Luxepack
Not Confirmed
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Brand Name : CALCIUM GLUCONATE IN...

Luxepack
Not Confirmed
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Fresenius Kabi USA

Dosage Form : SOLUTION; INTRAVENOUS

Proprietary Name : CALCIUM GLUCONATE IN SOD...

Dosage Strength : 2GM/100ML (20MG/ML)

Approval Date : 2021-06-17

Application Number : 208418

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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