APPLICATION
ANDA212868
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-26
LATEST ACTION
2026-03-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ATROPINE SULFATEPrescription
ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
ATROPINE SULFATEPrescription
ATROPINE SULFATE 1MG/10ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
ATROPINE SULFATEPrescription
ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2026-03-18Labeling · Supplement 5 · standardAP
2023-04-07Labeling · Supplement 3 · standardAP
2022-11-23Manufacturing (CMC) · Supplement 2 · standardAP
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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