Orange Book product

CROMOLYN SODIUM 10MG/ML

Orange Book ANDA 074209 · EUGIA PHARMA SPECIALITIES LTD · Discontinued

Key facts

Proprietary name CROMOLYN SODIUM
Active ingredients CROMOLYN SODIUM
Strength 10MG/ML
Dosage form SOLUTION
Route INHALATION
Application ANDA074209
Applicant holder EUGIA PHARMA SPECIALITIES LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 26, 1994

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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