FDA NDA · NDA208401

QBRELIS

lisinopril

Sponsor: AZURITY

APPLICATION

NDA208401

TYPE

NDA

ORIGINAL APPROVAL

2016-07-29

LATEST ACTION

2017-07-28

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

QBRELIS · ReferencePrescription

LISINOPRIL 1MG/ML · SOLUTION · ORAL

2017-07-28Labeling · Supplement 2 · standard — Label ↗AP

2016-07-29Type 3 - New Dosage Form · 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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