Assyro AI

Orange Book product · Generic (ANDA)

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Generic (ANDA)ANDA 202217DISCN NOVEL LABS INC

At a glance

Aug 20, 2014

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 20, 2014

    12 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Strength

5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM

Dosage form

FOR SOLUTION, TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 202217

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.