FDA NDA · NDA203568

KYNAMRO

Sponsor: KASTLE THERAPS LLC

APPLICATION

NDA203568

TYPE

NDA

ORIGINAL APPROVAL

2013-01-29

LATEST ACTION

2019-03-18

ROUTE

SUBCUTANEOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

KYNAMRO · ReferenceDiscontinued

MIPOMERSEN SODIUM 200MG/ML (200MG/ML) · SOLUTION · SUBCUTANEOUS

2019-03-18Labeling · Supplement 11 · 901 required — Letter ↗AP

2017-10-25REMS · Supplement 9 — Letter ↗AP

2016-05-23Labeling · Supplement 8 · 901 required — Letter ↗AP

2015-07-28REMS · Supplement 5 — Letter ↗AP

2015-07-08Manufacturing (CMC) · Supplement 7 · standardAP

2015-07-01Manufacturing (CMC) · Supplement 6 · standardAP

2015-02-26Labeling · Supplement 4 · standard — Letter ↗AP

2014-05-07REMS · Supplement 2 — Letter ↗AP

2013-01-29Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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