Orange Book product

THIAMINE HYDROCHLORIDE 100MG/ML

Orange Book ANDA 208703 · EUGIA PHARMA SPECIALITIES LTD · Prescription

Key facts

Proprietary name THIAMINE HYDROCHLORIDE
Active ingredients THIAMINE HYDROCHLORIDE
Strength 100MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA208703
Applicant holder EUGIA PHARMA SPECIALITIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 20, 2022

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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