← FDA DRUG APPROVALS

FDA NDA · NDA213581

ATROPINE SULFATE

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA213581
TYPE
NDA
ORIGINAL APPROVAL
2022-03-15
LATEST ACTION
2022-03-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

ATROPINE SULFATE · ReferencePrescription
ATROPINE SULFATE 1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-03-15Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →