Orange Book product

CROMOLYN SODIUM 4%

Orange Book ANDA 075282 · SANDOZ INC · Prescription

Key facts

Proprietary name CROMOLYN SODIUM
Active ingredients CROMOLYN SODIUM
Strength 4%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA075282
Applicant holder SANDOZ INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 16, 1999

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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