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FDA NDA · NDA209112

ASCOR

ascorbic acid

Sponsor: MCGUFF

APPLICATION
NDA209112
TYPE
NDA
ORIGINAL APPROVAL
2017-10-02
LATEST ACTION
2024-01-17
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ASCOR · ReferencePrescription
ASCORBIC ACID 25,000MG/50ML (500MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-01-17Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2023-04-23Manufacturing (CMC) · Supplement 8 — Review ↗AP
2022-07-08Labeling · Supplement 7 · standard — Letter ↗AP
2017-10-02Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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