Orange Book product

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM 66%;10%

Orange Book ANDA 215049 · ANNORA PHARMA PRIVATE LTD · Prescription

Key facts

Proprietary name DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Active ingredients DIATRIZOATE MEGLUMINE, DIATRIZOATE SODIUM
Strength 66%;10%
Dosage form SOLUTION
Route ORAL, RECTAL
Application ANDA215049
Applicant holder ANNORA PHARMA PRIVATE LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 17, 2023

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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