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Aranesp

darbepoetin alpha

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Aranesp
Proper name
darbepoetin alpha
Licence type
351(a)
BLA number
103951
Applicant
Amgen Inc.
Center
CDER
Presentations
49
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
100MCG/0.5ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
100MCG/0.5ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
100MCG/0.5ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
100MCG/0.5ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
100MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx September 17, 2001
100MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc September 17, 2001
10MCG/0.4ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx —
150MCG/0.3ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
150MCG/0.3ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
150MCG/0.3ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
150MCG/0.3ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
150MCG/0.75ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc July 19, 2002
150MCG/0.75ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc December 12, 2003
200MCG/0.4ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
200MCG/0.4ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
200MCG/0.4ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
200MCG/0.4ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
200MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx September 17, 2001
200MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc September 17, 2001
25MCG/0.42ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 12, 2003
25MCG/0.42ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
25MCG/0.42ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
25MCG/0.42ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
25MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx September 17, 2001
25MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc September 17, 2001
300MCG/0.6ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
300MCG/0.6ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
300MCG/0.6ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
300MCG/0.6ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
300MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc July 19, 2002
300MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc December 12, 2003
40MCG/0.4ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 12, 2003
40MCG/0.4ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
40MCG/0.4ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
40MCG/0.4ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
40MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx September 17, 2001
40MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc September 17, 2001
500MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc July 19, 2002
500MCG/1ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
500MCG/1ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
500MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc December 12, 2003
500MCG/1ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
500MCG/1ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
60MCG/0.3ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Disc December 17, 2002
60MCG/0.3ML Injection Intravenous, Subcutaneous Pre-Filled Syringe Rx December 12, 2003
60MCG/0.3ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
60MCG/0.3ML Injection Intravenous, Subcutaneous Autoinjector Disc June 29, 2006
60MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx September 17, 2001
60MCG/1ML Injection Intravenous, Subcutaneous Single-Dose Vial Disc September 17, 2001

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity