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FDA NDA · NDA208686

ENALAPRIL MALEATE

Sponsor: AZURITY

APPLICATION
NDA208686
TYPE
NDA
ORIGINAL APPROVAL
2016-09-20
LATEST ACTION
2017-07-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EPANED · ReferencePrescription
ENALAPRIL MALEATE 1MG/ML · SOLUTION · ORAL

Approval history

2017-07-28Labeling · Supplement 2 · standardLabelAP
2016-09-20Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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