Orange Book product

SILDENAFIL CITRATE EQ 100MG BASE

Orange Book ANDA 202023 · AMNEAL PHARMACEUTICALS OF NY LLC · Prescription

Key facts

Proprietary name SILDENAFIL CITRATE
Active ingredients SILDENAFIL CITRATE
Strength EQ 100MG BASE
Dosage form TABLET
Route ORAL
Application ANDA202023
Applicant holder AMNEAL PHARMACEUTICALS OF NY LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 27, 2018

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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