Orange Book product · Brand (NDA)

SUPREP BOWEL PREP KIT

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Brand (NDA)NDA 022372TE AARX AZURITY

View MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE family Open on FDA Orange Book

At a glance

Aug 05, 2010

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Aug 05, 2010
16 yr 1 mo ago
Today
Exclusivity ends · ODE-315
Orphan-drug exclusivity (7 years)
Aug 05, 2027
in 1 yr 2 mo

Pharmaceutical detail

Active ingredient

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Strength

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Dosage form

SOLUTION

Route

ORAL

TE code

Application

NDA 022372

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

ODE-315Orphan-drug exclusivity (7 years)
Aug 05, 2027
in 1 yr 2 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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