Orange Book product

ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product…

Orange Book ANDA 072652 · PHARMOBEDIENT CONSULTING LLC · Discontinued

Key facts

Proprietary name ALBUTEROL SULFATE
Active ingredients ALBUTEROL SULFATE
Strength EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form SOLUTION
Route INHALATION
Application ANDA072652
Applicant holder PHARMOBEDIENT CONSULTING LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 21, 1992

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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