Product Details for: Mircera

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous, Subcutaneous
30MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
002
Injection
Intravenous, Subcutaneous
50MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
003
Injection
Intravenous, Subcutaneous
75MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
004
Injection
Intravenous, Subcutaneous
100MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
005
Injection
Intravenous, Subcutaneous
120MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
006
Injection
Intravenous, Subcutaneous
150MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
007
Injection
Intravenous, Subcutaneous
200MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
008
Injection
Intravenous, Subcutaneous
250MCG/0.3ML
Pre-Filled Syringe
351(a)
Mircera
Rx
009
Injection
Intravenous, Subcutaneous
360MCG/0.6ML
Pre-Filled Syringe
351(a)
Mircera
Rx
010
Injection
Intravenous, Subcutaneous
50MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
011
Injection
Intravenous, Subcutaneous
100MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
012
Injection
Intravenous, Subcutaneous
200MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
013
Injection
Intravenous, Subcutaneous
300MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
014
Injection
Intravenous, Subcutaneous
400MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
015
Injection
Intravenous, Subcutaneous
600MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
016
Injection
Intravenous, Subcutaneous
1,000MCG/ML
Single-Dose Vial
351(a)
Mircera
Disc
017
Injection
Intravenous, Subcutaneous
400MCG/0.6ML
Pre-Filled Syringe
351(a)
Mircera
Disc
018
Injection
Intravenous, Subcutaneous
600MCG/0.6ML
Pre-Filled Syringe
351(a)
Mircera
Disc
019
Injection
Intravenous, Subcutaneous
800MCG/0.6ML
Pre-Filled Syringe
351(a)
Mircera
Disc
Proper Name
methoxy polyethylene glycol-epoetin beta
BLA Number
125164
Applicant
Vifor (International) Inc.
Original Approval Date
April 28, 2016
Date of First Licensure
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