Assyro AI

Orange Book product · Generic (ANDA)

CROMOLYN SODIUM

CROMOLYN SODIUM

Generic (ANDA)ANDA 075333DISCN HIKMA

At a glance

Apr 30, 2002

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 30, 2002

    24 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CROMOLYN SODIUM

Strength

10MG/ML

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

ANDA 075333

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CROMOLYN SODIUM

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.