Orange Book product

CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML)

Orange Book ANDA 201276 · MYLAN INSTITUTIONAL LLC · Prescription

Key facts

Proprietary name CIDOFOVIR
Active ingredients CIDOFOVIR
Strength EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
Dosage form SOLUTION
Route INTRAVENOUS
Application ANDA201276
Applicant holder MYLAN INSTITUTIONAL LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jun 27, 2012

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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