← FDA DRUG APPROVALS

FDA NDA · NDA019797

PEG 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE

polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

Sponsor: AZURITY

APPLICATION
NDA019797
TYPE
NDA
ORIGINAL APPROVAL
1991-04-22
LATEST ACTION
2021-05-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

NULYTELY · ReferencePrescription
POLYETHYLENE GLYCOL 3350 420GM/BOT, POTASSIUM CHLORIDE 1.48GM/BOT, SODIUM BICARBONATE 5.72GM/BOT, SODIUM CHLORIDE 11.2GM/BOT · FOR SOLUTION · ORAL
NULYTELY-FLAVORED · ReferencePrescription
POLYETHYLENE GLYCOL 3350 420GM/BOT, POTASSIUM CHLORIDE 1.48GM/BOT, SODIUM BICARBONATE 5.72GM/BOT, SODIUM CHLORIDE 11.2GM/BOT · FOR SOLUTION · ORAL

Approval history

2021-05-14Labeling · Supplement 29 · standard — Letter ↗AP
2013-09-23Labeling · Supplement 22 · standard — Label ↗AP
2010-01-27Labeling · Supplement 18 · standardAP
2003-08-07Manufacturing (CMC) · Supplement 14 · standardAP
2003-06-30Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2001-02-23Manufacturing (CMC) · Supplement 12 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 10 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 9 · standardAP
1999-10-09Manufacturing (CMC) · Supplement 11 · standardAP
1999-03-25Manufacturing (CMC) · Supplement 8 · standardAP
1997-12-10Labeling · Supplement 7 · standardAP
1997-12-10Labeling · Supplement 6 · standardAP
1997-06-03Manufacturing (CMC) · Supplement 5 · standardAP
1996-11-04Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 3 · standardAP
1994-11-18Manufacturing (CMC) · Supplement 2 · standardAP
1993-04-29Manufacturing (CMC) · Supplement 1 · standardAP
1991-04-22Type 4 - New Combination · Original · standard — Medication Guide ↗AP
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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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