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FDA NDA · NDA021146

ATROPINE SULFATE

Sponsor: HOSPIRA

APPLICATION
NDA021146
TYPE
NDA
ORIGINAL APPROVAL
2001-07-09
LATEST ACTION
2025-07-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 1MG/10ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-07-30Labeling · Supplement 37 · standard — Label ↗AP
2020-11-30Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2020-06-24Labeling · Supplement 22 · standard — Label ↗AP
2017-11-01Labeling · Supplement 19 · standard — Label ↗AP
2017-08-17Manufacturing (CMC) · Supplement 18 — Label ↗AP
2017-01-31Labeling · Supplement 16 · standard — Letter ↗AP
2015-10-30Labeling · Supplement 15 · standard — Letter ↗AP
2014-03-12Manufacturing (CMC) · Supplement 14 · standardAP
2001-07-09Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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