Orange Book product

ALBUTEROL SULFATE EQ 0.5% BASE

Orange Book ANDA 074543 · SENTISS AG · Prescription

Key facts

Proprietary name ALBUTEROL SULFATE
Active ingredients ALBUTEROL SULFATE
Strength EQ 0.5% BASE
Dosage form SOLUTION
Route INHALATION
Application ANDA074543
Applicant holder SENTISS AG
Marketing status Prescription
Therapeutic equivalence (TE) code AN
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 15, 1998

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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