Assyro AI

Orange Book product · Generic (ANDA)

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Generic (ANDA)ANDA 090145TE AARX NOVEL LABS INC

At a glance

Jan 25, 2012

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 25, 2012

    14 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Dosage form

FOR SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 090145

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

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.