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FDA NDA · NDA210583

ANJESO

Sponsor: BAUDAX

APPLICATION
NDA210583
TYPE
NDA
ORIGINAL APPROVAL
2020-02-20
LATEST ACTION
2021-07-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ANJESO · ReferenceDiscontinued
MELOXICAM 30MG/ML (30MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2021-07-15Labeling · Supplement 2 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 1 · standard — Letter ↗AP
2020-02-20Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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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