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FDA NDA · NDA214652

ATROPINE SULFATE

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA214652
TYPE
NDA
ORIGINAL APPROVAL
2020-09-29
LATEST ACTION
2026-02-04
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

ATROPINE SULFATE · ReferenceDiscontinued
ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) · SOLUTION · INTRAVENOUS
ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 1MG/ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-04Labeling · Supplement 5 · standard — Letter ↗AP
2025-02-18Labeling · Supplement 4 · standard — Letter ↗AP
2020-09-29Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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