← FDA DRUG APPROVALS

FDA NDA · NDA202799

OMONTYS

Sponsor: TAKEDA PHARMS USA

APPLICATION

NDA202799

TYPE

NDA

ORIGINAL APPROVAL

2012-03-27

LATEST ACTION

2012-12-04

ROUTE

INTRAVENOUS, SUBCUTANEOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

OMONTYSDiscontinued

PEGINESATIDE ACETATE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYSDiscontinued

PEGINESATIDE ACETATE EQ 10MG BASE/ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

OMONTYS PRESERVATIVE FREEDiscontinued

PEGINESATIDE ACETATE EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS

Approval history

2012-12-04Labeling · Supplement 1 · standard — Label ↗AP

2012-03-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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