Orange Book product

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017%

Orange Book ANDA 076749 · NEPHRON PHARMACEUTICALS CORP · Prescription

Key facts

Proprietary name ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Active ingredients ALBUTEROL SULFATE, IPRATROPIUM BROMIDE
Strength EQ 0.083% BASE;0.017%
Dosage form SOLUTION
Route INHALATION
Application ANDA076749
Applicant holder NEPHRON PHARMACEUTICALS CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AN
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Dec 31, 2007

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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