Orange Book product

ACETIC ACID 2%

Orange Book ANDA 040607 · SCIEGEN PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name ACETIC ACID
Active ingredients ACETIC ACID, GLACIAL
Strength 2%
Dosage form SOLUTION/DROPS
Route OTIC
Application ANDA040607
Applicant holder SCIEGEN PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Feb 24, 2005

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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