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FDA BLA · BLA203313

RYZODEG 70/30

Sponsor: NOVO

APPLICATION
BLA203313
TYPE
BLA
ORIGINAL APPROVAL
2015-09-25
LATEST ACTION
2022-10-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

RYZODEG 70/30Discontinued
INSULIN ASPART 90 UNITS/3ML, INSULIN DEGLUDEC 210 UNITS/3ML (30 UNITS/ML · SOLUTION · SUBCUTANEOUS

Approval history

2022-10-06Labeling · Supplement 14 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 10 · 901 required — Label ↗AP
2019-11-15Labeling · Supplement 9 · standard — Label ↗AP
2018-08-09Efficacy · Supplement 5 · standard — Letter ↗AP
2016-12-16Efficacy · Supplement 2 · standard — Letter ↗AP
2016-06-24Labeling · Supplement 3 · standardAP
2016-06-24Labeling · Supplement 4 · standard — Label ↗AP
2016-03-07Manufacturing (CMC) · Supplement 1 · standardAP
2015-09-25Type 4 - New Combination · Original · standard — Pediatric Clinical Pharmacology Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics 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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