APPLICATION
NDA215040
TYPE
NDA
ORIGINAL APPROVAL
2024-02-13
LATEST ACTION
2024-02-13
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
LEGUBETI · ReferenceDiscontinued
ACETYLCYSTEINE LYSINE EQ 2.5GM BASE/PACKET · FOR SOLUTION · ORAL
LEGUBETI · ReferenceDiscontinued
ACETYLCYSTEINE LYSINE EQ 500MG BASE/PACKET · FOR SOLUTION · ORAL
Approval history
2024-02-13Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standard — Letter ↗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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