Orange Book product

AMINOCAPROIC ACID 0.25GM/ML

Orange Book ANDA 213213 · SUNNY PHARMTECH INC · Prescription

Key facts

Proprietary name AMINOCAPROIC ACID
Active ingredients AMINOCAPROIC ACID
Strength 0.25GM/ML
Dosage form SOLUTION
Route ORAL
Application ANDA213213
Applicant holder SUNNY PHARMTECH INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 27, 2023

At a glance

  • 10–99 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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