Orange Book product

AEROLATE JR 130MG

Orange Book ANDA 085075 · FLEMING AND CO PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name AEROLATE JR
Active ingredients THEOPHYLLINE
Strength 130MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA085075
Applicant holder FLEMING AND CO PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 24, 1986

At a glance

  • None 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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