← FDA DRUG APPROVALS

FDA NDA · NDA020742

BSS

balanced salt solution

Sponsor: ALCON

APPLICATION
NDA020742
TYPE
NDA
ORIGINAL APPROVAL
1997-12-10
LATEST ACTION
2015-11-06
ROUTE
OPHTHALMIC, IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BSS · ReferencePrescription
CALCIUM CHLORIDE 0.48MG/ML, MAGNESIUM CHLORIDE 0.3MG/ML, POTASSIUM CHLORIDE 0.75MG/ML, SODIUM ACETATE 3.9MG/ML, SODIUM CHLORIDE 6.4MG/ML, SODIUM CITRATE 1.7MG/ML · SOLUTION · IRRIGATION

Approval history

2015-11-06Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2015-11-06Labeling · Supplement 25 · standard — Letter ↗AP
2012-11-15Manufacturing (CMC) · Supplement 24 · standardAP
2009-04-23Manufacturing (CMC) · Supplement 20 · standard — Letter ↗AP
2004-09-30Labeling · Supplement 8 · standard — Label ↗AP
2004-05-25Labeling · Supplement 5 · standard — Label ↗AP
2004-05-25Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2003-07-09Labeling · Supplement 3 · standard — Label ↗AP
2003-04-15Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2002-10-30Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-10Type 4 - New Combination · Original · standardAP
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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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