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FDA BLA · BLA208751

FIASP

insulin aspart injection

Sponsor: NOVO

APPLICATION
BLA208751
TYPE
BLA
ORIGINAL APPROVAL
2017-09-29
LATEST ACTION
2023-06-21
ROUTE
SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FIASP PENFILLPrescription
INSULIN ASPART 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS
FIASPPrescription
INSULIN ASPART 1000 UNITS/10ML (100 UNITS/ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS
FIASP FLEXTOUCHPrescription
INSULIN ASPART 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2023-06-21Labeling · Supplement 20 · standard — Letter ↗AP
2019-12-19Efficacy · Supplement 10 · standard — Letter ↗AP
2019-12-19Efficacy · Supplement 11 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 12 · standard — Letter ↗AP
2019-10-21Labeling · Supplement 13 · 901 required — Label ↗AP
2019-10-21Efficacy · Supplement 8 · standard — Label ↗AP
2018-09-24Manufacturing (CMC) · Supplement 3 — Other ↗AP
2018-09-04Labeling · Supplement 5 · standard — Other ↗AP
2018-07-22Manufacturing (CMC) · Supplement 2AP
2018-03-06Labeling · Supplement 1 · standard — Other ↗AP
2017-09-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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