← FDA DRUG APPROVALS

FDA NDA · NDA208151

ATROPINE SULFATE

Sponsor: ALCON LABS INC

APPLICATION
NDA208151
TYPE
NDA
ORIGINAL APPROVAL
2016-12-01
LATEST ACTION
2022-08-12
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

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

Approval history

2022-08-12Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2016-12-01Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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.

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 →