Orange Book product · Brand (NDA)

SUFLAVE

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE

Brand (NDA)NDA 215344RX AZURITY

Jun 15, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 15, 2023
3 yr 1 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Jun 15, 2026
4 d ago
Today
Patent 12239659 expires
Listed method-of-use patent (U-4143) expiration.
Jun 14, 2044
in 18 yr 3 mo
Patent 12433914 expires
Listed method-of-use patent (U-4143) expiration.
Jun 14, 2044
in 18 yr 3 mo
Patent 12594298 expires
Listed drug product patent expiration.
Jun 14, 2044
in 18 yr 3 mo
Patent 12290529 expires
Listed drug product patent expiration.
Aug 02, 2044
in 18 yr 5 mo

Active ingredient

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE

Strength

0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 215344

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12239659	Jun 14, 2044	in 18 yr 3 mo	U-4143
12433914	Jun 14, 2044	in 18 yr 3 mo	U-4143
12594298	Jun 14, 2044	in 18 yr 3 mo	Product
12290529	Aug 02, 2044	in 18 yr 5 mo	Product