Orange Book product

MINOXIDIL EXTRA STRENGTH (FOR MEN) 5%

Orange Book ANDA 075438 · AUROBINDO PHARMA LTD · Over the counter

Key facts

Proprietary name MINOXIDIL EXTRA STRENGTH (FOR MEN)
Active ingredients MINOXIDIL
Strength 5%
Dosage form SOLUTION
Route TOPICAL
Application ANDA075438
Applicant holder AUROBINDO PHARMA LTD
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 27, 2003

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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