Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202799

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OMONTYS (PEGINESATIDE ACETATE)
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 007
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS (PEGINESATIDE ACETATE)
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 008
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 001
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 002
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 003
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 004
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 005
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE)
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)
Marketing Status: Discontinued

Active Ingredient: PEGINESATIDE ACETATE
Proprietary Name: OMONTYS PRESERVATIVE FREE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202799
Product Number: 006
Approval Date: Mar 27, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information