← FDA DRUG APPROVALS

FDA NDA · NDA018469

BSS PLUS

balanced salt solution enriched with bicarbonate, dextrose, and glutathione

Sponsor: ALCON

APPLICATION
NDA018469
TYPE
NDA
ORIGINAL APPROVAL
1981-10-28
LATEST ACTION
2023-04-13
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BSS PLUS · ReferencePrescription
CALCIUM CHLORIDE 0.154MG/ML, DEXTROSE 0.92MG/ML, GLUTATHIONE DISULFIDE 0.184MG/ML, MAGNESIUM CHLORIDE 0.2MG/ML, POTASSIUM CHLORIDE 0.38MG/ML, SODIUM BICARBONATE 2.1MG/ML, SODIUM CHLORIDE 7.14MG/ML, SODIUM PHOSPHATE 0.42MG/ML · SOLUTION · IRRIGATION

Approval history

2023-04-13Labeling · Supplement 60 · standard — Letter ↗AP
2016-04-27Labeling · Supplement 56 · standard — Letter ↗AP
2015-11-06Labeling · Supplement 54 · standard — Letter ↗AP
2015-11-06Manufacturing (CMC) · Supplement 55 · standard — Letter ↗AP
2015-02-09Manufacturing (CMC) · Supplement 53 · standardAP
2013-05-29Manufacturing (CMC) · Supplement 52 · standard — Label ↗AP
2004-12-20Manufacturing (CMC) · Supplement 40 · standard — Letter ↗AP
2004-12-20Labeling · Supplement 41 · standard — Letter ↗AP
2004-05-25Labeling · Supplement 38 · standard — Letter ↗AP
2004-05-25Manufacturing (CMC) · Supplement 39 · standard — Letter ↗AP
2003-07-16Manufacturing (CMC) · Supplement 36 · standard — Letter ↗AP
2003-07-16Labeling · Supplement 37 · standard — Letter ↗AP
1999-10-18Manufacturing (CMC) · Supplement 35 · standardAP
1998-12-29Labeling · Supplement 32 · standardAP
1998-03-20Manufacturing (CMC) · Supplement 34 · standardAP
1997-11-03Manufacturing (CMC) · Supplement 33 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 31 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 30 · standardAP
1994-08-19Manufacturing (CMC) · Supplement 28 · standardAP
1994-07-13Labeling · Supplement 29 · standardAP
1993-06-15Manufacturing (CMC) · Supplement 23 · standardAP
1993-06-08Labeling · Supplement 27 · standardAP
1993-03-24Manufacturing (CMC) · Supplement 17 · standardAP
1992-03-23Manufacturing (CMC) · Supplement 25 · standardAP
1991-12-30Manufacturing (CMC) · Supplement 26 · standardAP
1990-06-29Labeling · Supplement 21AP
1990-06-29Manufacturing (CMC) · Supplement 24 · standardAP
1989-10-24Manufacturing (CMC) · Supplement 19 · standardAP
1988-11-30Manufacturing (CMC) · Supplement 16 · standardAP
1988-11-17Labeling · Supplement 14AP
1988-11-08Manufacturing (CMC) · Supplement 18 · standardAP
1988-09-30Manufacturing (CMC) · Supplement 15 · standardAP
1988-06-08Manufacturing (CMC) · Supplement 13 · standardAP
1987-09-10Manufacturing (CMC) · Supplement 12 · standardAP
1987-03-27Manufacturing (CMC) · Supplement 10 · standardAP
1986-09-29Manufacturing (CMC) · Supplement 11 · standardAP
1986-02-13Manufacturing (CMC) · Supplement 8 · standardAP
1986-01-24Manufacturing (CMC) · Supplement 5 · standardAP
1985-10-22Manufacturing (CMC) · Supplement 7 · standardAP
1985-06-17Manufacturing (CMC) · Supplement 6 · 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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