FDA NDA · NDA020213

MIOCHOL E

acetylcholine chloride

Sponsor: BAUSCH AND LOMB

APPLICATION

NDA020213

TYPE

NDA

ORIGINAL APPROVAL

1993-09-22

LATEST ACTION

2016-06-17

ROUTE

OPHTHALMIC

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Prescription

Products

MIOCHOL-E · ReferencePrescription

ACETYLCHOLINE CHLORIDE 20MG/VIAL · FOR SOLUTION · OPHTHALMIC

2016-06-17Manufacturing (CMC) · Supplement 14 · standardAP

2006-05-30Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP

2000-01-24Manufacturing (CMC) · Supplement 5 · standardAP

1998-04-29Manufacturing (CMC) · Supplement 4 · standardAP

1996-10-16Manufacturing (CMC) · Supplement 3 · standardAP

1996-02-29Manufacturing (CMC) · Supplement 1 · standardAP

1995-08-18Labeling · Supplement 2 · standardAP

1993-09-22Type 3 - New Dosage Form · Original · 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.

Weekly Briefing

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