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Approved Drug Products containing Follitropin alfa beta listed in the FDA Orange Book. Original Data : FDA Website

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01 12EMD SERONO

02 8ORGANON USA INC

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PharmaCompass

01

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FOLLITROPIN ALFA/BETA

Brand Name : GONAL-F

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 75 IU/VIAL

Approval Date :

Application Number : 20378

RX/OTC/DISCN :

RLD :

TE Code :

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02

Luxepack
Not Confirmed
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FOLLITROPIN ALFA/BETA

Brand Name : GONAL-F

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 150 IU/VIAL

Approval Date :

Application Number : 20378

RX/OTC/DISCN :

RLD :

TE Code :

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03

Luxepack
Not Confirmed
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Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : GONAL-F

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 37.5 IU/VIAL

Approval Date :

Application Number : 20378

RX/OTC/DISCN :

RLD :

TE Code :

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04

Luxepack
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Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : GONAL-F

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 1,050 IU/VIAL

Approval Date :

Application Number : 20378

RX/OTC/DISCN :

RLD :

TE Code :

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05

Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : GONAL-F

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 450 IU/VIAL

Approval Date :

Application Number : 20378

RX/OTC/DISCN :

RLD :

TE Code :

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06

Luxepack
Not Confirmed
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Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : FOLLISTIM

Dosage Form : INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

Dosage Strength : 75 IU/VIAL

Approval Date :

Application Number : 20582

RX/OTC/DISCN :

RLD :

TE Code :

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07

Luxepack
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Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : FOLLISTIM

Dosage Form : INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

Dosage Strength : 150 IU/VIAL

Approval Date :

Application Number : 20582

RX/OTC/DISCN :

RLD :

TE Code :

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08

Luxepack
Not Confirmed
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FOLLITROPIN ALFA/BETA

Brand Name : FOLLISTIM AQ

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 300 IU/0.36ML

Approval Date :

Application Number : 21211

RX/OTC/DISCN :

RLD :

TE Code :

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09

Luxepack
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FOLLITROPIN ALFA/BETA

Brand Name : FOLLISTIM AQ

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 600 IU/0.72ML

Approval Date :

Application Number : 21211

RX/OTC/DISCN :

RLD :

TE Code :

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10

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FOLLITROPIN ALFA/BETA

Brand Name : FOLLISTIM AQ

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 150 IU/0.18ML

Approval Date :

Application Number : 21211

RX/OTC/DISCN :

RLD :

TE Code :

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