Orange Book product

AMINOCAPROIC ACID 1GM

Orange Book ANDA 209060 · SUNNY PHARMTECH INC · Prescription

Key facts

Proprietary name AMINOCAPROIC ACID
Active ingredients AMINOCAPROIC ACID
Strength 1GM
Dosage form TABLET
Route ORAL
Application ANDA209060
Applicant holder SUNNY PHARMTECH INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 27, 2018

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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